Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane — Class II medical device recall Z-0632-2018
Terminated recall by Cook Inc., reported 2018-02-21, distributed nationwide. Central venous catheters may not fit over guide wire potentially causing procedure delay.
| Recall number | Z-0632-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Inc., Bloomington, IN, United States |
| Recall initiated | 2017-07-31 |
| Classified | 2018-02-15 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2019-05-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, ES, GB, IN, IT |
| Quantity | 75 |
| Lot numbers | 7252432, 7252434, 7621767, NS5914753 |
Product
Central Venous Catheter Set Heparin Coated Triple Lumen Polyurethane, Catalog Identifiers: C-UTLM-501J-25-6.5-WCE-BH, C-UTLM-501J-BH Product Usage: The central venous catheter is designed for treatment of critically ill patients and is suggested for: 1. Continuous or intermittent drug infusions; 2. Central venous blood pressure monitoring (CVP); 3. Acute hyperalimentation; 4. Blood sampling; 5. Delivery of whole blood or blood products; 6. Simultaneous, separate infusion of drugs
Reason for recall
Central venous catheters may not fit over guide wire potentially causing procedure delay.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0632-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.