Z-1353-2025Class II
CV BASIC PUMP PACK , Model No WECV23D
American Contract Systems, Inc. / initiated 2025-02-06 / Open, Classified / root cause: manufacturing process
American Contract Systems Inc began a recall of CV BASIC PUMP PACK , Model No WECV23D on . FDA classified it as Class II and gives the reason as "ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1353-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- American Contract Systems, Inc.
- Product
- CV BASIC PUMP PACK , Model No WECV23D
- Product code
- OEZ Cardiovascular Procedure Kit
- 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.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- The affected distributor was notified via email on 2/16/25, and an updated letter was provided on 2/18/25. The distributor was instructed to notify their end users. Customers were provided with a list of impacted components which are included in the affected trays. Customers were provided with a labeling template and instructed to add warning labels to affected procedure trays to ensure the affected components are discarded.
- Quantity in commerce
- 134 kits
- Distribution
- US Nationwide distribution in the state of OH.
- Product codes and lots
- UDI-DI 00191072206664 Lots 939241 71-050895 71-051582 71-052213
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1331-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1332-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1333-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1334-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1335-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1336-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1337-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1338-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1339-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1340-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1341-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1342-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1343-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1344-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1345-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1346-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1347-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1348-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1349-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1350-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1351-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1352-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1353-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1354-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1355-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1356-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1357-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1358-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1359-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1360-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1361-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1362-2025 | Class II | Ongoing | Voluntary: Firm initiated |
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