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U.S. Department of Health and Human Services

Class 2 Device Recall AVID Medical, Inc.

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  Class 2 Device Recall AVID Medical, Inc. see related information
Date Initiated by Firm February 18, 2020
Create Date March 19, 2020
Recall Status1 Terminated 3 on November 23, 2020
Recall Number Z-1522-2020
Recall Event ID 85049
Product Classification Obstetrical kit - Product Code OKV
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.
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.   
Recalling Firm/
Manufacturer
Avid Medical, Inc.
9000 Westmont Dr
Toano VA 23168-9351
For Additional Information Contact Nichole Early
828-338-7568
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 2,632 each
Distribution US: AZ, CA, IL, IN, MD, MS, NJ, NV, NY, TN, TX WI, VA
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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