FDAClass IIAugust 14, 2024

American Contract Systems Biopsy Drape Pack convenience recall: Sterility Concern

American Contract Systems Biopsy Drape Pack convenience kit

Why was American Contract Systems Biopsy Drape Pack convenience 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?

UDI-DI 00191072202246; Lot 981241; Exp. Date 1/19/2025

Product
American Contract Systems Biopsy Drape Pack convenience kit
Recalling firm
American Contract Systems, Inc.
Quantity
224
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)
Open FDA enforcement record Latest recalls