FDA recall Z-1449-2022

Aesculap Implant Systems LLC · Class II · device

Product

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

United States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and WI

Key facts

Status
Terminated
Initiation date
2019-10-01
Report date
2022-07-27
Termination date
2024-06-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1449-2022