PlainRecalls
FDA Devices Moderate Class II Ongoing

ACS Cath Lab Pack

Reported: May 18, 2022 Initiated: March 22, 2022 #Z-1040-2022

Product Description

ACS Cath Lab Pack

Reason for Recall

Product was sterilized with a higher than specification EO concentration.

Details

Units Affected
10 packs
Distribution
US Nationwide distribution in the states of IL, MO, NE, and TX.
Location
Kansas City, MO

Frequently Asked Questions

What product was recalled?
ACS Cath Lab Pack. Recalled by American Contract Systems, Inc.. Units affected: 10 packs.
Why was this product recalled?
Product was sterilized with a higher than specification EO concentration.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 18, 2022. Severity: Moderate. Recall number: Z-1040-2022.