Z-1343-2025Class II
CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
American Contract Systems, Inc. / initiated 2025-02-06 / Open, Classified / root cause: manufacturing process
American Contract Systems Inc began a recall of CENTRAL LINE PICC , Model No LLCL44H LLCL44H-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-1343-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- American Contract Systems, Inc.
- Product
- CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
- Product code
- OKE Port Introducer 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
- 1420
- Distribution
- US Nationwide distribution in the state of OH.
- Product codes and lots
- UDI-DI 00191072219602 Lots 70-050707 70-050860 70-051149 70-051713 70-052363 70-053044
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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