1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray recall
1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
Why was 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray 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?
1) ACS Spine Pack - Model LOSP35D, Lot 966221; UDI 00191072154613 2) ACS Lumbar/Back Set Up Tray - Model SALB85AG, Lot 973221; UDI: 00191072127280
- Product
- 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
- Recalling firm
- American Contract Systems, Inc.
- Quantity
- 72 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)