Recall Z-1449-2022— Aesculap Implant Systems LLC
Class II · Terminated
Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2019-10-01, terminated 2024-06-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.. Reason: Packaging seal integrity not validated resulting in a lack of sterility assurance..
- Recalling firm
- Aesculap Implant Systems LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-10-01
- Terminated
- 2024-06-06
- Firm location
- Center Valley, PA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.