PlainRecalls
FDA Devices Moderate Class II Ongoing

THORACIC PACK , Model No UTTC82Y UTTC82AA-01

Reported: March 26, 2025 Initiated: February 6, 2025 #Z-1361-2025

Product Description

THORACIC PACK , Model No UTTC82Y UTTC82AA-01

Reason for Recall

ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

Details

Units Affected
40 kits
Distribution
US Nationwide distribution in the state of OH.
Location
Tiffin, OH

Frequently Asked Questions

What product was recalled?
THORACIC PACK , Model No UTTC82Y UTTC82AA-01. Recalled by American Contract Systems Inc. Units affected: 40 kits.
Why was this product recalled?
ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 26, 2025. Severity: Moderate. Recall number: Z-1361-2025.