Exact FDA event identifier

Event 66372

5 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: September 09, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Hospira Inc.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 5

* 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; * 2) Product labeled in part: List No. 14254-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port 2 CLAVE Y-Sites, 0.2 Micron Filter, 112 Inch, Non-DEHP; *** 3) Product labeled in part: List No. 14687-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port, CLAVE Y-Site; 103 Inch, Non-DEHP; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.

Z-2058-2016

Recall number: Z-2058-2016
Initiated: September 09, 2013
Classification: Class II
Status: Terminated
Recalling firm: Hospira Inc.
Quantity: 1) 941,982 units; 2) 1,200 units; 3) 4,449,939 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.

Code information

***** US DISTRIBUTION ***** *** 1) List Number: 14212-04-28; Lot Numbers: 962235H , 030565H , 030575H , 081425H , 090515H , 100905H , 100915H , 102255H , 102265H , 122515H , 122525H , 143405H , 152655H , 152665H , 152675H , 161375H , 161385H , 161395H , 170955H , 172025H , 172035H , 172045H , 143415H , 241805H , 251735H , 251745H , 250845H ; *** 2) List Number: 14254-08-28; Lot Number: 072055H; *** 3) List Number: 14687-04-28; Lot Numbers: 650935H , 710435H , 720925H , 721925H , 721895H , 721325H , 721905H , 730175H , 761965H , 771895H , 772175H , 780725H , 781395H , 780715H , 800135H , 800145H , 810185H , 851685H , 840795H , 861775H , 861785H , 810155H , 880695H , 901065H , 901055H , 901095H , 921945H , 020765H , 020775H , 020785H , 020795H , 030185H , 030195H , 042005H , 052335H , 052755H , 052345H , 061035H , 070625H , 080325H , 080335H , 091085H , 092935H , 132125H , 142805H , 153285H , 153495H , 171435H , 180405H , 211275H , 201225H , 201235H ; ***** FOREIGN DISTRIBUTION ***** *** 4) List Number: 12193-83-24; Lot Numbers: 662095H , 712345H , 741615H , 880705H , 890735H , 920595H , 952665H , 020485H ; *** 5) List Number: 12193-92-28; Lot Numbers: 063285H , 071115H , 071475H , 133335H , 140205H , 171535H , 180045H , 250515H , 281895H ; *** 6) List Number: 19194-83-24; Lot Numbers: 662115H , 702305H , 721795H , 721805H , 732055H , 732035H , 732045H , 732065H ; *** 7) List Number: 19194-84-24; Lot Numbers: 881945H, 950975H; *** 8) List Number: 12194-92-28; Lot Numbers: 071105H , 140085H , 151445H , 180055H ; *** 9) List Number: 12195-83-24; Lot Numbers: 662105H , 712355H , 821545H , 880715H , 890745H , 910745H ; *** 10) List Number: 12195-84-24; Lot Numbers: 681645H , 681655H , 702295H , 721695H , 721785H , 741635H , 741355H , 761495H , 771395H , 782265H , 782275H , 791315H , 890755H , 900455H , 940615H , 951325H , 010725H , 011475H , 020895H , 021415H ; *** 11) List Number: 12195-92-28; Lot Numbers: 063185H , 063195H , 071125H , 102395H , 102405H , 111705H , 111715H , 113055H , 112865H , 131865H , 133405H , 140115H , 153385H , 162385H , 171445H , 180065H , 180075H , 200855H , 210865H , 201895H , 221315H , 250525H , 260235H , 271645H , 270825H ; *** 12) List Number: 12196-83-24; Lot Numbers: 662125H , 702315H , 702325H , 712245H , 712255H ; *** 13) List Number: 12196-84-24; Lot Number: 871295H; *** 14) List Number: 12196-92-28; Lot Numbers: 071135H , 131835H , 151545H , 211645H , 250505H , 281575H ; *** 15) List Number: 14001-07-28; Lot Numbers: 810195H , 810205H , 831395H , 830775H , 890985H , 902085H , 220125H ; *** 16) List Number: 14001-82-28; Lot Numbers: 890945H , 932935H , 151585H ; *** 17) List Number: 14001-83-28; Lot Numbers: 752235H , 851525H , 871535H , 890765H , 900465H , 910215H , 951335H , 960405H , 010735H , 010755H , 020905H , 032185H , 040965H , 053775H , 061775H ; *** 18) List Number: 14001-84-28; Lot Numbers: 752254H , 830785H , 851515H , 890775H , 950355H ; *** 19) List Number: 14001-92-28; Lot Numbers: 063255H , 081605H , 081615H , 091115H , 161615H , 162365H , 180395H , 190925H , 220155H , 190935H , 190945H ; *** 20) List Number: 14007-82-01; Lot Numbers: 811595H, 160345H; *** 21) List Number: 14007-92-28; Lot Numbers: 251485H, 270875H; *** 22) List Number: 14009-82-01; Lot Numbers: 811525H, 840885H, 910095H; *** 23) List Number: 14011-82-01; Lot Number: 811555H; *** 24) List Number: 14012-92-28; Lot Numbers: 162315H, 231615H; *** 25) List Number: 14013-82-01; Lot Numbers: 811535H, 840895H, 920855H; *** 26) List Number: 14014-92-28; Lot Number: 162305H; *** 27) List Number: 14015-82-01; Lot Numbers: 811515H, 910105H; *** 28) List Number: 14017-82-01; Lot Number: 811705H; *** 29) List Number: 14017-92-28; Lot Numbers: 112855H, 200955H; *** 30) List Number: 14022-92-28; Lot Numbers: 162325H, 172265H; *** 31) List Number: 14212-92-28; Lot Numbers: 071955H , 091685H , 100885H , 110505H , 113655H , 143425H , 161415H ; *** 32) List Number: 19673-53-24; Lot Numbers: 662035H , 701715H , 721575H , 910115H , 910515H , 961555H , 011455H , 031335H , 061995H , 102145H , 111615H , 132705H , 180615H , 201815H , 220725H , 200275H , 241365H

Distribution pattern

US (Nationwide) Distribution

device · product 2 of 5

* 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING PIN, TWO INTEGRAL CLAVE PORTS AND CLAVE ON SECONDARY PORT; NOMINAL LENGTH: 104 IN (264 CM); PRIMING VOLUME: 19 ML; * 2) Product labeled in part: 14952-01; LIFESHIELD; HEMA Y-TYPE BLOOD PLUMSET, NONVENTED WITH 210 MICRON FILTER AND OPTION-LOK, DUAL CHANNEL, CLAVE SECONDARY PORT; NOMINAL LENGTH: 102 IN (260 CM); PRIMING VOLUME: 69 ML; * 3) Product labeled in part: 14954-28; LIFESHIELD; LIFECARE 5000 WITH PROXIMAL 0.2 MICRON FILTER-0L, CONVERTIBLE PIN, DUAL CHANNEL, INTEGRAL Y CLAVE, NON-DEHP; NOMINAL LENGTH: 112 IN (284 CM); PRIMING VOLUME: 24 ML; * 4) Product labeled in part: List No. 19553-12; LifeShield; LATEX-FREE; PLUM EXTENSION SET WITH CLAVE SECONDARY PORT; NOMINAL LENGTH: 28 IN (71 CM); PRIMING VOLUME: 7.1 ML; SET CONTAINS DEHP; * 5) Product labeled in part: 19556-28; LIFESHIELD; PLUMSET HEMOSET 100 ML BURETTE, DUAL CHANNEL CASSETTE WITH CLAVE, SECURE LOCK, NON-DEHP NOMINAL LENGTH: 98 IN (249 CM); PRIMING VOLUME: 17 ML; * 6) Product labeled in part: 19557-28; LIFESHIELD; PLUMSET CONVERTIBLE PIN, TWO INTEGRAL CLAVES, CLAVE SECONDARY PORT AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 110 IN (279 CM); PRIMING VOLUME: 21.4 ML; * 7) Product labeled in part: 19671-28; LIFESHIELD; CONVERTIBLE PP LIFECARE 5000 CASSETTE W/CLAVE MICRODRIP SOLUSET 150 X 60 DPM, CLAVE INJECTION SITE, NON DEHP; NOMINAL LENGTH: 124 IN (315 CM); PRIMING VOLUME: 13 ML; * 8) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML; * 9) Product labeled in part: List No. 19685-28; LifeShield; LATEX-FREE; PLUMSET, PRIMARY CONVERTIBLE PP W/ SIGHT CHAMBER, THREE WAY STOPCOCK, CLAVE INJECTION PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 136 IN (345 CM); PRIMING VOLUME: 24 ML; USA; * 10) Product labeled in part: 19720-28; LIFESHIELD; PLUM SET, CONV P.P, DUAL CHANNEL 3 CLAVE PORTS,IN LINE CHECK VAL OPTION LOK, NON-DEHP.; NOMINAL LENGTH:145 IN (368 CM); PRIMING VOLUME:13 ML; * 11) Product labeled in part: 19721-28; LIFESHIELD; SOLUSET 150ML BUR,CONV P.P DUAL CHANNEL 4 CLAVE PORTS IN LINE CHECK VAL OPTION LOK, NON-DEHP; NOMINAL LENGTH: 145 IN (368 CM); PRIMING VOLUME: 15 ML: * 12) Product labeled in part: 19729-28; LIFESHIELD; CONV. DUAL CHANNEL PLUMSET WITH CLAVES, AND SECURE LOK, NON-DEHP; NOMINAL LENGTH: 96 IN (244 CM); PRIMING VOLUME: 18 ML; *** 13) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.

Z-2059-2016

Recall number: Z-2059-2016
Initiated: September 09, 2013
Classification: Class II
Status: Terminated
Recalling firm: Hospira Inc.
Quantity: 1) 65,904 units; 2) 270,321 units; 3) 32,088 units; 4) 4,944 units; 5) 14,064 units; 6) 503,328 units; 7) 7,560 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.

Code information

***** US DISTRIBUTION ***** *** 1) List Number: 14952-04-01; Lot Numbers: 681775H , 711485H , 750515H , 770115H , 782335H , 800765H , 840515H , 880315H , 962345H , 052015H , 061965H , 121605H , 210165H , 231625H , 231835H , 281085H , 281155H ; *** 2) List Number: 14954-04-28; Lot Numbers: 662045H , 712055H , 051935H , 132675H , 151615H , 231375H , 260465H , 260485H ; *** 3) List Number: 19553-04-12; Lot Number: 751145H; *** 4) List Number: 19556-04-28; Lot Numbers: 750295H , 801115H , 900585H , 040145H , 143175H , 210195H , 281095H ; *** 5) List Number: 19557-04-28; Lot Numbers: 962435H , 040155H , 070705H , 071735H , 082165H , 091245H , 091255H , 091365H , 102515H , 200795H , 200945H , 210835H , 241705H , 280465H , 280475H , 240135H ; *** 6) List Number: 19671-04-28; Lot Numbers: 701785H , 730805H , 811605H , 861435H , 880255H ; *** 7) List Number: 19683-04-28; Lot Numbers: 782315H , 042125H , 211065H , 231825H ; *** 8) List Number: 19685-04-28; Lot Numbers: 682285H , 791285H , 850175H ; *** 9) List Number: 19720-04-28; Lot Numbers: 962305H , 092585H , 121635H , 180645H , 221715H , 260525H ; *** 10) List Number: 19721-04-28; Lot Numbers: 962315H, 132735H; *** 11) List Number: 19729-04-28; Lot Numbers: 032195H , 082285H , 121645H , 170415H , 200235H ; *** 12) List Number: 19734-04-28; Lot Number: 133265H; ***** CANADA DISTRIBUTION ***** *** 13) List Number: 14951-04-48; Lot Numbers: 761875H , 761905H , 821525H , 830335H , 870625H , 870635H , 880125H , 051955H , 092565H , 142995H , 211715H , 231355H , 271495H , 281105H ; *** 14) List Number: 14952-04-01; Lot Numbers: 681775H , 711485H , 750515H , 770115H , 782335H , 800765H , 840515H , 880315H , 962345H , 052015H , 061965H , 121605H , 210165H , 231625H , 231835H , 281085H , 281155H ; *** 15) List Number: 14954-04-28; Lot Numbers: 662045H , 712055H , 051935H , 132675H , 151615H , 231375H , 260465H , 260485H ; *** 16) List Number: 19732-04-28; Lot Numbers: 114405H , 143545H , 170385H , 170425H , 170395H , 210225H , 201655H , 260535H , 291595H

Distribution pattern

US (Nationwide) Distribution

device · product 3 of 5

*** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site, Non-Vented, 110 Inch, Non-DEHP; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.

Z-2060-2016

Recall number: Z-2060-2016
Initiated: September 09, 2013
Classification: Class II
Status: Terminated
Recalling firm: Hospira Inc.
Quantity: 3,920,932 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.

Code information

***** CANADA DISTRIBUTION ***** *** 1) List Number 14220-28-01

Distribution pattern

US (Nationwide) Distribution

device · product 4 of 5

* 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET, MICRODRIP,PP SOLUSET,FILTER, 3 CLAVE PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 124 IN (315 IN); PRIMING VOLUME: 14 ML; * 2) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.

Z-2061-2016

Recall number: Z-2061-2016
Initiated: September 09, 2013
Classification: Class II
Status: Terminated
Recalling firm: Hospira Inc.
Quantity: 3,920,932 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.

Code information

***** US DISTRIBUTION ***** *** 1) List Number: 19734-04-28; Lot Number: 133265H; ***** CANADA DISTRIBUTION ***** *** 1) List Number: 19732-04-28; Lot Numbers: 114405H , 143545H , 170385H , 170425H , 170395H , 210225H , 201655H , 260535H , 291595H

Distribution pattern

US (Nationwide) Distribution

device · product 5 of 5

* 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML; * 2) Product labeled in part: List No. 19685-28; LifeShield; LATEX-FREE; PLUMSET, PRIMARY CONVERTIBLE PP W/ SIGHT CHAMBER, THREE WAY STOPCOCK, CLAVE INJECTION PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 136 IN (345 CM); PRIMING VOLUME: 24 ML; * 3) Product labeled in part: 19720-28; LIFESHIELD; PLUM SET, CONV P.P, DUAL CHANNEL 3 CLAVE PORTS,IN LINE CHECK VAL OPTION LOK, NON-DEHP.; NOMINAL LENGTH:145 IN (368 CM); PRIMING VOLUME:13 ML; * 4) Product labeled in part: 19721-28; LIFESHIELD; SOLUSET 150ML BUR,CONV P.P DUAL CHANNEL 4 CLAVE PORTS IN LINE CHECK VAL OPTION LOK, NON-DEHP; NOMINAL LENGTH: 145 IN (368 CM); PRIMING VOLUME: 15 ML: * 5) Product labeled in part: 19729-28; LIFESHIELD; CONV. DUAL CHANNEL PLUMSET WITH CLAVES, AND SECURE LOK, NON-DEHP; NOMINAL LENGTH: 96 IN (244 CM); PRIMING VOLUME: 18 ML; * 6) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML; Product Usage: The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.

Z-2062-2016

Recall number: Z-2062-2016
Initiated: September 09, 2013
Classification: Class II
Status: Terminated
Recalling firm: Hospira Inc.
Quantity: 3,920,932 units in total

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.

Code information

Distribution pattern

US (Nationwide) Distribution