Recall Z-0647-2017 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Centurion Medical Products Corporation
Multi-Med Single Lumen Catheters sold in Centurion convenience kits. The Multi-Med catheter is indicated for use in patients requiring administration of solutions, blood sampling, and central venous pressure monitoring.
| Date | Dec 2, 2016 (initiated Oct 21, 2016) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 1000 kits |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955839 | MULTI-MED MULTI-LUMEN CENTRAL VENOUS CATHETER Baxter Edwards, Mar 25, 1996 |