Reported Jul 27, 2022 · Terminated
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit,…
Aesculap Implant Systems LLC
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: Aesculap Implant Systems LLC · 3773 Corporate Pkwy · Center Valley, PA · 18034-8217
Is this the product you have?
- Aesculap Sterile disposable fleece drape
- Product code
GA414individually packaged50 pieces per shipping unitproduct code SZ380R
- Lot codes and dates
- UDI-DI (GTIN)
04038653067862lots 55195337152024524520976985217246052249972and 52340448
- UDI-DI (GTIN)
- Amount recalled
- 4500 pieces
This recall covers 14 products
The agency filed one notice per product. You are reading one of them; the other 13 are below.
1 more are in the archive.
Where it was sold
Why it was recalled
Packaging seal integrity not validated resulting in a lack of sterility assurance.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
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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