Reported Mar 25, 2020 · Terminated
Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and…
Avid Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Avid Medical, Inc. · 9000 Westmont Dr · Toano, VA · 23168-9351
Is this the product you have?
- Custom procedure trays containing medical components needed to facilitate patient procedures and to perform minor and major patient surgeries. Multiple item and lot numbers.
- Lot codes and dates
- Item Codes
ADVC065-18ADVC068-21ADVH078-17ADVM042-07
- Lot Numbers
1324410134415813565611366768137201213735181375096137734913780721378073137986113812711381272
- Expiration dates05/01/2020-09/30/2021
- Item Codes
- Amount recalled
- 400 each
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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