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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85049

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

Open FDA event record

Event summary

Timeline bucket
February 18, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Avid Medical, 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

9 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 9

Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

Z-1515-2020
Recall number
Z-1515-2020
Initiated
February 18, 2020
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
21,326 each

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

Code information

Item Codes: ADBR003-14, ADBR008-19, ADBR010-10, ADBR012-13, ADBR014-14, ADBR015-15, ADBR020-05, ADBR021-23, ADBR022-25, ADBR032-06, ADCO004-21, ADCO021-15, ADCO027-13, ADCO028-17, ADCO033-06, ADCO038-05, ADEU001-05, ADVC006-21, ADVC008-27, ADVC009-27, ADVC011-24, ADVC017-29, ADVC018-27, ADVC025-16, ADVC034-23, ADVC043-17, ADVC058-14, ADVC059-19, ADVC085-08, ADVC086-08, ADVC089-08, ADVC092-07, ADVC200-06, ADVC204-06, ADVC208-07, ADVD001-20, ADVD002-17, ADVD015-06, ADVD018-08, ADVG003-34, ADVG004-26, ADVG005-29, ADVG014-21, ADVG019-25, ADVG019-25, ADVG021-29, ADVG030-22, ADVG041-21, ADVG049-10, ADVH007-31, ADVH008-32, ADVH009-38, ADVH096-02, ADVM001-22, ADVM009-15, ADVM011-19, ADVM012-15, ADVM017-21, ADVM020-16, ADVM021-21, ADVM022-18, ADVM024-19, ADVM033-13, ADVM036-08, ADVM038-08, ADVM039-06, ADVM039-07, ADVR003-23, ADVR012-20, ADVR036-06, ADVT020-13, ADVT024-12, ADVT026-13, ADVT028-13, ADVT035-11, ADVU019-16, ADVU025-15, ADVU026-16, ADVU027-20, ADVU028-14, ADVU037-13, ADVU040-06, ADVU042-07, CHWE008, CHWE011, CMRL001-02, CNSC013-06, EDHN004-04, MADN030-06, MADN032-06, MADN033-07, MDVC001, NWHR006-01, NWHR006-02, NWHR007, NWHR013-01, NWHR016-01, NWHR018-01, NWHR020-01, PCHM005-08, RMRI010-20, RVRH009-01, SHER009-13, SHER013-10, SHER021-06, SHER023-08, SHER026-06, SINA130-01, SINA201-01, SINA204-01, SINA205-01, SINA206-01, SINA207-01, SINA210-01, SINA225, SINA226, SINA226-01, SINA230, SINA232, VANA017-01, YAVA105-04, YAVA106-03, YAVA108-04, YAVA112-04, YAVA116-04, YAVA121-06, YAVA121-07, YAVA123-07. Lot Numbers: 1322955, 1331381, 1331528, 1334505, 1334575, 1336084, 1336360, 1336778, 1336906, 1338531, 1338698, 1338855, 1338880, 1338925, 1339216, 1339567, 1340277, 1340685, 1340692, 1340698, 1341118, 1341392, 1341413, 1341835, 1342023, 1342031, 1342537, 1342538, 1342707, 1342844, 1342973, 1343173, 1343221, 1343850, 1344150, 1344402, 1344805, 1344967, 1345175, 1345302, 1345319, 1345538, 1345798, 1346559, 1346562, 1347895, 1348045, 1348111, 1348213, 1348215, 1348338, 1348392, 1348413, 1348753, 1348976, 1349028, 1349390, 1349727, 1349728, 1349947, 1350158, 1350293, 1350294, 1350295, 1350299, 1350547, 1351204, 1351577, 1352730, 1353391, 1353395, 1353396, 1353406, 1353987, 1357567, 1357572, 1357941, 1358280, 1358550, 1358762, 1358884, 1359049, 1359245, 1359246, 1359295, 1359298, 1359985, 1360227, 1360228, 1360327, 1360332, 1360333, 1360362, 1360689, 1360701, 1360795, 1360993, 1361000, 1361102, 1361103, 1361145, 1361159, 1361207, 1361378, 1361444, 1361567, 1361910, 1362076, 1362166, 1362315, 1362388, 1362389, 1362402, 1362558, 1362725, 1362851, 1362872, 1362873, 1362916, 1363040, 1363105, 1363218, 1363227, 1363238, 1363241, 1363253, 1363254, 1363561, 1363635, 1363637, 1363766, 1363932, 1364250, 1364304, 1364311, 1364312, 1364325, 1364326, 1364327, 1364464, 1364697, 1364948, 1365295, 1365501, 1365502, 1365661, 1365662, 1365664, 1365740, 1365742, 1365967, 1365968, 1365975, 1365976, 1366362, 1366363, 1366423, 1366425, 1366495, 1366665, 1366763, 1366769, 1366777, 1366915, 1367017, 1367021, 1367109, 1367212, 1367231, 1367336, 1367408, 1367413, 1367780, 1367781, 1367895, 1367988, 1367991, 1367998, 1368000, 1368407, 1368408, 1368409, 1368589, 1368713, 1368729, 1368733, 1368734, 1368735, 1368757, 1368941, 1368944, 1369037, 1369133, 1369141, 1369377, 1369379, 1369389, 1369401, 1369402, 1369403, 1369404, 1369417, 1369621, 1369716, 1369721, 1369789, 1369791, 1369932, 1370081, 1370082, 1370083, 1370085, 1370232, 1370238, 1370371, 1370376, 1370379, 1370380, 1370385, 1370386, 1370392, 1370513, 1370515, 1370516, 1370892, 1370893, 1370901, 1371096, 1371099, 1371105, 1371177, 1371220, 1371221, 1371237, 1371321, 1371491, 1371589, 1371644, 1371787, 1371870, 1371877, 1372019, 1372020, 1372021, 1372141,1372147, 1372212, 1372293, 1372299, 1372307, 1372401, 1372404, 1372467, 1372468, 1372471, 1372472, 1372473, 1372474, 1372476, 1372480, 1372495, 1372499, 1372983, 1372984, 1373146, 1373153, 1373228, 1373232, 1373340, 1373343, 1373346, 1373521, 1373721, 1373722, 1373905, 1373966, 1373971, 1374233, 1374252, 1374309, 1374571, 1374575, 1374893, 1374904, 1374989, 1374990, 1375095, 1375310, 1375315, 1375644, 1375650, 1375651, 1375655, 1375785, 1375857, 1375858, 1375872, 1376194, 1376229, 1376630, 1376672, 1376914, 1376915, 1376918, 1376989, 1377097, 1377101, 1377160, 1377278, 1377371, 1377372, 1377467, 1377523, 1377528, 1377532, 1377536, 1377630, 1377644, 1377800, 1377852, 1378410, 1378506, 1378656, 1379204, 1379543, 1379569, 1379571, 1379676, 1379685, 1379688, 1379932, 1379933, 1379939, 1380731, 1380737, 1380743, 1380751, 1380775, 1380776, 1380785, 1380786, 1380812, 1380823, 1380886, 1380892, 1380894, 1380916, 1380923, 1380927, 1380932, 1380939, 1381099, 1381453, 1381724, 1381755, 1381926, 1382029, 1382224, 1382225, 1382226, 1382228, 1382348, 1382490, 1382530, 1382572, 1382759, 1382760, 1382761, 1383413, 1383497, 1383534, 1383539, 1383544, 1383794, 1383795, 1383934, 1383935, 1383936, 1383939, 1383940, 1383947, 1384279, 1384527, 1384728, 1384786, 1384855, 1385587, 1388152. Expiration dates: 02/01/2020 thru 02/06/2023.

Distribution pattern

US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA

device · product 2 of 9

Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

Z-1516-2020
Recall number
Z-1516-2020
Initiated
February 18, 2020
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
1,906 each

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

Code information

Item Codes:ADVC033-16, ADVG034-15, ADVU018-24, JNTH001-04, JNTH001-05, JNTH002-05, SHER019-07, YAVA100-05. Lot Numbers: 1344066, 1344358, 1353858, 1353860, 1354012, 1359439, 1361116, 1361767, 1363232, 1365746, 1379393. Expiration dates: 2/28/21 thru 7/30/2022.

Distribution pattern

US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA

device · product 3 of 9

Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

Z-1517-2020
Recall number
Z-1517-2020
Initiated
February 18, 2020
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
1,644 each

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

Code information

Item Codes: ADBR043-08, ADCO001-20, ADCO001-20, ADCO002-15, ADCO005-29, ADCO007-21, ADVC015-23, ADVC032-21, ADVC046-12, ADVH073-13, ADVM040-07, ADVM050-02, SHER020-10, SINA223, VAHT026-07, YAVA115-04, YAVA130, YAVA131-03. Lot numbers: 1333107, 1333471, 1336767, 1337370, 1339098, 1339331, 1342016, 1347760, 1347896, 1348407, 1353068, 1353419, 1354811, 1357043, 1359839, 1360420, 1361445, 1363245, 1365971, 1367018, 1367137, 1367218, 1367987, 1368726, 1369130, 1370525, 1370700, 1370929, 1371222, 1372022, 1372310, 1372407, 1373347, 1374864, 1375307, 1375787, 1376196, 1376397, 1378227, 1380392, 1380874, 1381757, 1382980, 1383533, 1384526, 1385192. Expiration Dates: 9/30/2020-10/17/2022

Distribution pattern

US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA

device · product 4 of 9

Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

Z-1518-2020
Recall number
Z-1518-2020
Initiated
February 18, 2020
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
400 each

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

Code information

Item Codes: ADVC065-18, ADVC068-21, ADVH078-17, ADVM042-07. Lot Numbers: 1324410, 1344158, 1356561, 1366768, 1372012, 1373518, 1375096, 1377349, 1378072, 1378073, 1379861, 1381271, 1381272. Expiration dates: 05/01/2020-09/30/2021.

Distribution pattern

US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA

device · product 5 of 9

Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

Z-1519-2020
Recall number
Z-1519-2020
Initiated
February 18, 2020
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
230 each

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

Code information

Item Codes: SHER010-12. Lot Numbers: 1339900, 1352089, 1361835, 1370391, 1372029. Expiration dates: 12/15/2020-09/05/2021. ,

Distribution pattern

US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA

device · product 6 of 9

Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

Z-1520-2020
Recall number
Z-1520-2020
Initiated
February 18, 2020
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
1,001 each

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

Code information

Item Codes: ADBR013-17, ADCO013-17, ADCO015-17, ADCO016-17, ADVG010-24, ADVH032-25, ADVH049-17, ADVM015-26, ADVM018-25, ADVR034-09, ADVU020-17, NWHR010-01, SINA212. Lot Codes: 1320621, 1329060, 1337288, 1337499, 1340260, 1342539, 1343857, 1344733, 1356016, 1356568, 1357442, 1357815, 1359042, 1362293, 1362314, 1363219, 1363243, 1363557, 1363636, 1363778, 1365656, 1368746, 1370233, 1371692, 1373730, 1375786, 1376609, 1377795, 1378737, 1379931, 1380256, 1381718, 1381720, 1381721, 1384785. Expiration Dates: 06/30/2020-06/25/2021.1370391, 1372029. Expiration dates: 12/15/2020-09/05/2021. ,

Distribution pattern

US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA

device · product 7 of 9

Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

Z-1521-2020
Recall number
Z-1521-2020
Initiated
February 18, 2020
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
628

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

Code information

Item Codes: ADCO026-17, SINA217. Lot Numbers: 1336261, 1361099, 1363225, 1367696, 1371095, 1374420, 1376394, 1383159. Expiration dates: 02/10/2020-11/18/2022.

Distribution pattern

US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA

device · product 8 of 9

Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

Z-1522-2020
Recall number
Z-1522-2020
Initiated
February 18, 2020
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
2,632 each

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

Code information

Item Codes: ADBR023-09, ADVC026-20, ADVC026-20, ADVC028-19, ADVG020-28, ADVG040-16, ADVG042-11, ADVH017-26, ADVH019-22, ADVM010-14, ADVT021-12, ADVU008-17, ADVU036-10, ADVU041-07, NWHR011-01, SHER007-10, SHER017-09, SINA215, SINA229, SINA246-01, YAVA102-04, YAVA114-07, YAVA118-02. Lot Numbers: 1334810, 1335648, 1336974, 1341358, 1341365, 1341404, 1342580, 1345312, 1345675, 1345677, 1350309, 1350975, 1353716, 1358493, 1359443, 1360017, 1362230, 1362875, 1362996, 1363269, 1365415, 1365448, 1365737, 1366054, 1368755, 1369662, 1369785, 1370089, 1370226, 1370706, 1370902, 1371225, 1371226, 1371322, 1372024, 1372478, 1373852, 1374118, 1375649, 1375790, 1377540, 1377798, 1378061, 1378483, 1379389, 1380106, 1380920, 1381113, 1382221, 1382231, 1383929, 1383931, 1384518. Expiration dates: 01/31/2020-11/08/2022.

Distribution pattern

US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA

device · product 9 of 9

Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.

Z-1523-2020
Recall number
Z-1523-2020
Initiated
February 18, 2020
Classification
Class II
Status
Terminated
Recalling firm
Avid Medical, Inc.
Quantity
5,004 each

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The medical procedure trays contain one or more recalled surgical gowns. The gowns were manufactured at locations that did not maintain proper environmental conditions. There is no assurance that the surgical gowns are sterile. An inadequately sterilized surgical gown could compromise a sterile field and increase the risk of a surgical site infection. Due to the configuration of the trays, the recalled gowns may come into contact with other components within the tray posing a risk of cross contamination.

Code information

Item Codes: ADBR019-16, ADBR019-17, ADBR025-09, ADBR048-01, ADCO014-17, ADVC001-23, ADVC001-25, ADVC004-24, ADVC007-30, ADVC201-05, ADVC202-07, ADVC205-06, ADVD004-16, ADVD017-06, ADVG011-23, ADVG012-21, ADVG013-19, ADVG015-22, ADVG016-32, ADVM019-17, ADVM034-11, ADVM041-08, ADVT030-21, ADVU012-17, ADVU013-16, ADVU014-23, ADVU015-18, NWHR001, SHER002-12, SHER004-12, SHER008-12, SHER011-11, SHER025-07, SINA207, VMCI005, YAVA125-08, YAVA127-05. Lot Numbers: 1320840, 1331256, 1331443, 1331444, 1331467, 1331929, 1335097, 1336484, 1337355, 1337359, 1338609, 1339352, 1341351, 1342664, 1342763, 1343707, 1343830, 1344151, 1345679, 1345802, 1349993, 1350160, 1350726, 1352818, 1353070, 1355493, 1356573, 1357429, 1358558, 1359285, 1361447, 1361826, 1362710, 1362918, 1363271, 1363423, 1363772, 1364857, 1365071, 1365738, 1366778, 1367348, 1367349, 1367351, 1367352, 1367582, 1367779, 1367999, 1368736, 1368738, 1369131, 1369132, 1369135, 1369139, 1369392, 1369413, 1370223, 1370236, 1370528, 1370649, 1371098, 1371223, 1371323, 1371328, 1371329, 1372015, 1372023, 1372295, 1372398, 1372498, 1373723, 1374239, 1375312, 1375313, 1375789, 1375871, 1376097, 1376457, 1376608, 1377366, 1377368, 1377526, 1377539, 1377708, 1378500, 1380560, 1380561, 1380562, 1380745, 1380760, 1380828, 1381741, 1382210, 1383542, 1383796, 1383932, 1383933, 1383941, 1384529, 1385588, 1386135. Expiration Dates: 03/31/2020-12/11/2022.

Distribution pattern

US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA

Field note

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