CLASS II ONGOING Device recall · Reported 26 Mar 2025 · FDA Enforcement Report
Cv Basic Pump Pack recalled by American Contract Systems
American Contract Systems is recalling Cv Basic Pump Pack, distributed nationwide in the US. The recall was initiated on 6 Feb 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1353-2025
- FDA event ID
- 96343
- Recalling firm
- American Contract Systems, Tiffin, OH
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 6 Feb 2025
- FDA classified
- 14 Mar 2025
- Reported
- 26 Mar 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 6 Feb 2025 | Recall initiated by company | |
| 14 Mar 2025 | Classified by FDA | +36 days |
| 26 Mar 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
CV BASIC PUMP PACK , Model No WECV23D
Where it was distributed
US Nationwide distribution in the state of OH.
Questions about this recall
Why was it 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 lots are affected?
UDI-DI 00191072206664 Lots 939241 71-050895 71-051582 71-052213
Where was it sold?
US Nationwide distribution in the state of OH.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
31 other products · FDA event 96343This product is part of a recall event; the main page for the event is Major Vascular Pack recalled by American Contract Systems.
More recalls from American Contract Systems
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| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Convenience Kits, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
| Device | CLASS II | Convenience Kit, CV B PACK recalled by American Contract Systems | American Contract Systems | Foreign Material | Nationwide |
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