Device product
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
Z-1449-2022
Product summary
- Event
- Event 90475
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4500 pieces
- Official record key
device-enforcement:Z-1449-2022
Official wording
Reason: Packaging seal integrity not validated resulting in a lack of sterility assurance.
Code information: UDI-DI (GTIN): 04038653067862, lots 551953371, 52024524, 52097698, 52172460, 52249972, and 52340448.
Distribution pattern: United States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and WI
Derived failure modes
-
Sterility assurance
lack of sterility