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

Recall number

Z-1523-2020

Recalling firm

Avid Medical, Inc.

Product

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

Status

Terminated

Initiated

2020-02-18

Posted

not on file

Terminated

2020-11-23

Reason

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.

Root cause

Other

Action

URGENT MEDICAL DEVICE RECALL NOTICE letters, dated February 18, 2020, were distributed to customers. Letter provides identification of the issue, health risk and action to take. Customers were instructed to take the following required actions: " Review all storage and usage locations and segregate and quarantine any trays with an item code and lot number listed on attached Exhibit A. " Complete and return the enclosed Recall Response Form to Sharon.moll@owens-minor .com. Please respond even if you do not have any trays subject to this recall. " Upon receipt of your completed Recall Response Form, product return instructions will be provided and a RGA will be issued, if you do have trays subject to this recall. " If you have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this Urgent Medical Device Recall Notice . Your assistance is appreciated and necessary to prevent any unintended use of the product. If you have any questions, call Sharon Moll at 757-566-9844.

Quantity

5,004 each

Distribution

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

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

OJH

Firm FEI

1047429

Firm city

Toano

Firm state

VA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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