Recall Z-1353-2025— American Contract Systems Inc

Name: FDA recall Z-1353-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-06

Class II · Ongoing

Class II FDA medical device recall by American Contract Systems Inc, initiated 2025-02-06. FDA's recall record names no specific 510(k) clearance for this event. Product: CV BASIC PUMP PACK , Model No WECV23D. Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment..

Recalling firm: American Contract Systems Inc
Classification: Class II
Status: Ongoing
Initiated: 2025-02-06
Firm location: Tiffin, OH, United States

Product description

CV BASIC PUMP PACK , Model No WECV23D

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.