FDAClass IIMay 18, 2022

ACS Lap Chole Pack recall

ACS Lap Chole Pack

Why was ACS Lap Chole 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 BLLC42M, Lot 643211 UDI: 00191072152473

Product
ACS Lap Chole Pack
Recalling firm
American Contract Systems, Inc.
Quantity
20 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