FDAClass IIMay 18, 2022

1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack recall

1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack

Why was 1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand 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?

1) ACS Arthroscopy Kit - Model LMAR15R, Lot 981221; UDI: 00191072152978 2) ACS Knee Kit - Model LWKN46N, Lot 966221; UDI: 00191072150158 3) ACS Hand Pack - Model FHHP63T, Lot 966221, UDI: 00191072149954

Product
1) ACS Arthroscopy Kit 2) ACS Knee Kit 3) ACS Hand Pack
Recalling firm
American Contract Systems, Inc.
Quantity
114 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)
Open FDA enforcement record Latest recalls