Aesculap Sterile disposable fleece drape recall: Sterility Concern
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
Why was Aesculap Sterile disposable fleece drape recalled?
Packaging seal integrity not validated resulting in a lack of sterility assurance.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI (GTIN): 04038653067862, lots 551953371, 52024524, 52097698, 52172460, 52249972, and 52340448.
- Product
- Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
- Recalling firm
- Aesculap Implant Systems LLC
- Quantity
- 4500 pieces
- Distribution
- United States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and WI
- Recall date
- July 27, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)