CV BASIC PUMP PACK , Model No WECV23D
FDA Recall #Z-1353-2025 — Class II — February 6, 2025
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.
Recalling Firm
American Contract Systems Inc — Tiffin, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
134 kits
Distribution
US Nationwide distribution in the state of OH.
Code Information
UDI-DI 00191072206664 Lots 939241 71-050895 71-051582 71-052213
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated