ACS Cath Lab Pack recall
ACS Cath Lab Pack
Why was ACS Cath Lab Pack recalled?
Product was sterilized with a higher than specification EO concentration.
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?
Model FTCL83K, Lot 982221 UDI: 00191072151360
- Product
- ACS Cath Lab Pack
- Recalling firm
- American Contract Systems, Inc.
- Quantity
- 10 packs
- Distribution
- US Nationwide distribution in the states of IL, MO, NE, and TX.
- Recall date
- May 18, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)