Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
- Company
- Aesculap Implant Systems Llc
- Recall Initiated
- October 1, 2019
- Terminated
- June 6, 2024
- Recall Number
- Z-1449-2022
- Quantity
- 4500 pieces
- Firm Location
- Center Valley, PA
Reason for Recall
Packaging seal integrity not validated resulting in a lack of sterility assurance.
Distribution
United States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and WI
Lot / Code Info
UDI-DI (GTIN): 04038653067862, lots 551953371, 52024524, 52097698, 52172460, 52249972, and 52340448.
Root Cause
Package design/selection
Action Taken
Recall notice issued October 1, 2019 via letter mailed USPS certified mail with return receipt. Customers are to review inventory, return affected product and the acknowledgement form. For questions contact (800) 282-9000 or email: emailorders@aesculapusa.com
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