FDA-Device2022-07-27Class II
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
Aesculap Implant Systems LLC
Hazard
Packaging seal integrity not validated resulting in a lack of sterility assurance.
Sold states
United States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and WI
Affected count
4500 pieces
Manufactured in
3773 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1449-2022Don't want to check this manually?
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