American Contract Systems Special Procedure Pack recall: Sterility Concern
American Contract Systems Special Procedure Pack convenience kit
Why was American Contract Systems Special Procedure Pack recalled?
Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber, which may have been compromised in sterility
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
(1) Model No SLSP77G; UDI-DI 00191072198730; Lot 981241; Exp. Date 1/19/2025; (2) Model No EJAG58A; UDI-DI 00191072190093; Lot 982241; Exp. Date 1/18/2025.
- Product
- American Contract Systems Special Procedure Pack convenience kit
- Recalling firm
- American Contract Systems, Inc.
- Quantity
- 112
- Distribution
- US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.
- Recall date
- August 14, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)