Z-1332-2025Class II
DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
American Contract Systems, Inc. / initiated 2025-02-06 / Open, Classified / root cause: manufacturing process
American Contract Systems Inc began a recall of DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01 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-1332-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- American Contract Systems, Inc.
- Product
- DR DIULUS INJECTION PACK, Model Nos. CCDU12C CCDU12D CCDU12D-01
- Product code
- LRO General Surgery Tray
- 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
- 1200 kits
- Distribution
- US Nationwide distribution in the state of OH.
- Product codes and lots
- 1. Model No. CCDU12C UDI-DI 00191072196323 Tray Lots 968241 70-050508 70-050945 70-051497 70-051882 2. Model No. CCDU12D UDI-DI 00191072229472 Tray Lot 70-052444 3. Model No. CCDU12D-01 UDI-DI 00191072229472 Tray Lot 70-052967
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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