Medical Pump Kits Recalled for Unconfirmed Sterilization and Functionality Loss
American Contract Systems Inc is recalling 134 CV Basic Pump Pack kits because the manufacturer cannot confirm sterilization requirements were met. Possible loss of functionality could delay or prolong patient treatment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II device recall involving failure to confirm sterilization requirements, which could cause equipment failure and treatment delays. No injuries or hospitalizations have been reported. Per the rubric, this qualifies as a risk-of-harm product without reported injury, scoring 3 (High).
Plain-English summary
American Contract Systems Inc is recalling 134 CV Basic Pump Pack kits (Model No WECV23D). The affected units are identified by lot numbers 939241, 71-050895, 71-051582, and 71-052213 (UDI-DI 00191072206664). The product was distributed in Ohio.
The manufacturer is unable to confirm that product sterilization assurance requirements were met. Sterilization is critical for medical devices. When sterilization cannot be assured, the device may present a safety concern.
Possible loss or lack of functionality in these pump kits may lead to delay or prolonged treatment. Patients and healthcare facilities with recalled units should stop using them and contact American Contract Systems Inc or the FDA for guidance on replacement or return.
The recalled product
- Product
- CV BASIC PUMP PACK , Model No WECV23D
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device
- Affected units
- 134
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 00191072206664 Lots 939241 71-050895 71-051582 71-052213
Distribution
Part of a larger recall action
This product is one of 32 recalled by American Contract Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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