FDA event 83549 · Recall Observatory

device · product 1 of 22

Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange Polyethylene-Lined*/Light Resistant Tubing, Prepierced Injection Site and OPTION-LOK. 1 unit per pouch; 48 pouches per case.

Z-0126-2020

Recall number: Z-0126-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 170,735 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 118790412, Lot number (UDI Number): 855505H (20887787009020, 10887787009023), 865135H (20887787009020, 10887787009023), 918695H (20887787009020, 10887787009023), 928085H (20887787009020, 10887787009023), 937325H (20887787009020, 10887787009023), 3864774 (20887787009020, 10887787009023), 3935434 (20887787009020, 10887787009023), 4011065 (20887787009020, 10887787009023), 4088425 (20887787009020, 10887787009023)

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 2 of 22

Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock, 104 Inch. 1 unit per pouch; 50 pouches per case

Z-0127-2020

Recall number: Z-0127-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 78,877 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 142560488, Lot number (UDI Number): 865455H (20887787005237, 10887787005230), 896215H (20887787005237, 10887787005230), 897455H (20887787005237, 10887787005230), 3864785 (20887787005237, 10887787005230), 4095291 (20887787005237, 10887787005230);

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 3 of 22

Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set Yellow Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, Secure Lock, 107 Inch. 1 unit per pouch; 48 pouches per case

Z-0128-2020

Recall number: Z-0128-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 1,536 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 149530489, Lot number (UDI Number): 925155H (20887787003226, 10887787003229)

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 4 of 22

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch. 1 unit per pouch; 50 pouches per case

Z-0129-2020

Recall number: Z-0129-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 73,710 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 163350455, Lot number (UDI Number): 855935H (20887787007316, 10887787007319), 855965H (20887787007316, 10887787007319), 876145H (20887787007316, 10887787007319), 885395H (20887787007316, 10887787007319), 896135H (20887787007316, 10887787007319), 936605H (20887787007316, 10887787007319), 3843263 (20887787007316, 10887787007319), 3864786 (20887787007316, 10887787007319)

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 5 of 22

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set, Microbore, CLAVE Y-Site, 118 Inch. 1 unit per pouch; 50 pouches per case

Z-0130-2020

Recall number: Z-0130-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 45,900 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 163620455, Lot number (UDI Number): 855645H (20887787007354, 10887787007357), 885415H (20887787007354, 10887787007357), 896625H (20887787007354, 10887787007357), 4008547 (10887787007357, 20887787007354)

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 6 of 22

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case

Z-0131-2020

Recall number: Z-0131-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 155,150 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 163630455, Lot number (UDI Number): 876175H (20887787007361, 10887787007364), 885385H (20887787007361, 10887787007364), 896995H (20887787007361, 10887787007364), 908235H (20887787007361, 10887787007364), 925755H (20887787007361, 10887787007364), 3843264 (20887787007361, 10887787007364)

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 7 of 22

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. 1 unit per pouch; 50 pouches per case

Z-0132-2020

Recall number: Z-0132-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 26,700 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 163730455, Lot number (UDI Number): 896225H (20887787007408, 10887787007401), 916845H (20887787007408, 10887787007401), 925825H (20887787007408, 10887787007401), 948155H (20887787007408, 10887787007401)

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 8 of 22

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch. 1 unit per pouch; 50 pouches per case

Z-0133-2020

Recall number: Z-0133-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 51,250 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 163830455, Lot number (UDI Number): 855665H (20887787007439, 10887787007432), 865495H (20887787007439, 10887787007432), 896195H (20887787007439, 10887787007432), 3849197 (20887787007439, 10887787007432), 4064964 (20887787007439, 10887787007432)

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 9 of 22

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case

Z-0134-2020

Recall number: Z-0134-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 19,350 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 163840455, Lot number (UDI Number): 855995H (20887787007446, 10887787007449), 865505H (20887787007446, 10887787007449), 876185H (20887787007446, 10887787007449)

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 10 of 22

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case

Z-0135-2020

Recall number: Z-0135-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 4,600 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 240100401, Lot number (UDI Number): 897525H (20887787009259, 10887787009252), 905915H (20887787009259, 10887787009252), 926235H (20887787009259, 10887787009252)

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 11 of 22

Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PRIMARY PLUMSET 15 Micron Filter in Sight Chamber, CLAVE Port, 0.2 Micron Filter, CLAVE Y-Site, PE Lined Light Resistant Tubing, Distal Microbore Tubing 272 cm / 15 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S.

Z-0136-2020

Recall number: Z-0136-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 14,850 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 140099238, Lot number 855565H

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 12 of 22

Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 272 cm / 15 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S.

Z-0137-2020

Recall number: Z-0137-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 280,826 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 140099290, Lot number 855575H, 865265H, 876065H, 885425H, 896175H, 918685H, 929095H, 925775H, 936455H, 945745H, 3849199, 3845287, 3864779.

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 13 of 22

Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 272 cm / 15 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S.

Z-0138-2020

Recall number: Z-0138-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 6,400 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 140099291, Lot number (UDI Number): 3981726 (10887709100166, 20887709100163), 4065006 (10887709100166, 20887709100163)

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 14 of 22

Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set, 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 269 cm / 14 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S.

Z-0139-2020

Recall number: Z-0139-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 521 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 154413190, Lot number 4105785

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 15 of 22

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case . Not distributed in the U.S.

Z-0140-2020

Recall number: Z-0140-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 2,327 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 163353155, Lot number 885685H, 3959757

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 16 of 22

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case . Not distributed in the U.S.

Z-0141-2020

Recall number: Z-0141-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 32,416 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 163359255, Lot number 855875H, 866155H, 876265H, 885645H, 887125H, 905965H, 945565H

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 17 of 22

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, 293 cm / 8.1 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case. Not distributed in the U.S.

Z-0142-2020

Recall number: Z-0142-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 5,443 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 163459255, Lot number 855755H, 876275H, 905975H

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 18 of 22

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case . Not distributed in the U.S.

Z-0143-2020

Recall number: Z-0143-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 400 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 163633155, Lot number 937585H, 3959758

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 19 of 22

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case . Not distributed in the U.S.

Z-0144-2020

Recall number: Z-0144-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 6,516 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 163639255, Lot number 855735H, 866165H, 897465H, 907305H, 929285H, 929425H

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 20 of 22

Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, 107 Inch. 1 unit per pouch; 48 pouches per case

Z-0145-2020

Recall number: Z-0145-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 7,920 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 240070401, Lot number (UDI Number): 896485H (20887787009228, 10887787009221), 915625H (20887787009228, 10887787009221), 3850054 (20887787009228, 10887787009221)

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 21 of 22

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case. Not distributed in the U.S.

Z-0146-2020

Recall number: Z-0146-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 120 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 240119201, Lot number 916205H

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

device · product 22 of 22

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case

Z-0147-2020

Recall number: Z-0147-2020
Initiated: July 29, 2019
Classification: Class II
Status: Terminated
Recalling firm: ICU Medical Inc
Quantity: 50 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Code information

Product Code: 240130401, Lot number (UDI Number): 885585H (20887787009266, 10887787009269), 925855H (20887787009266, 10887787009269),

Distribution pattern

Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.

Event summary

Source snapshots represented here

Every recalled product in this event

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