Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for use in pati
FDA device recall Z-0647-2017 · posted 2016-12-02 · Terminated
Recall details
- Recalling firm
- Centurion Medical Products Corporation
- Reason for recall
- The kits contain Multi-Med Single Lumen Catheters that have a potential for excess material to remain at the tip of the catheter from the manufacturing process. It is possible that the excess material may separate from the catheter during use and pose a potential risk of embolism, which could result in serious injury or death.
- Action taken
- Centurion sent an Urgent Recall Notice dated October 21, 2016, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to discontinue use of this product immediately, and forward a copy of this notice to other users to whom this product may have been further distributed. In addition, customers were instructed to complete the attached form at their earliest convenience and fax to 517-546-3356. For questions regarding this recall call 517-546-5400.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 1000 kits
- Distribution
- Nationwide Distribution
- Date initiated
- 2016-10-21
- Date posted
- 2016-12-02
- Date terminated
- 2017-07-20
- Location
- Williamston, MI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER (K955839) | Baxter Edwards | 1996-03-25 |