Z-1449-2022 Class II Terminated
FDA device recall Z-1449-2022 was initiated by Aesculap Implant Systems LLC on October 1, 2019 and is designated Class II. Reason for recall: Packaging seal integrity not validated resulting in a lack of sterility assurance. The recall status is terminated (terminated June 6, 2024). Affected quantity: 4500 pieces.
Recall Details
- Product Type
- Devices
- Report Date
- July 27, 2022
- Initiation Date
- October 1, 2019
- Termination Date
- June 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4500 pieces
Product Description
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
Reason for Recall
Packaging seal integrity not validated resulting in a lack of sterility assurance.
Distribution Pattern
United States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and WI
Code Information
UDI-DI (GTIN): 04038653067862, lots 551953371, 52024524, 52097698, 52172460, 52249972, and 52340448.