Recall Z-1352-2023 ยท FJS Catheter, Peritoneal, Long-Term Indwelling
Merit Medical Systems, Inc.
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
| Date | Apr 7, 2023 (initiated Feb 15, 2023) |
| Status | Open, Classified |
| Reason | Product that was built for design verification testing was inadvertently distributed to customers. |
| Root cause | Software Manufacturing/Software Deployment |
| Action | On 02/15/2023, the firm sent an "URGENT MEDICAL DEVICE RECALL NOTICE" via email to customers informing them that, Merit Medical Systems, Inc. is voluntarily conducting a recall of the Flex-Neck Catheter External Repair Kit due to an internal system error that inadvertently allowed an engineering configuration to be released for distribution to customers. Customers are instructed to: 1. Immediately determine if any of the devices identified in the attached Customer Response Form (CRF) are within their facility, quarantine them, and discontinue use and distribution. 2. Ensure that applicable pe |
| Quantity | 17 devices |
| Distribution | U.S. Nationwide distribution in the states of MD, MI, OH, and TX. O.U.S.: N/A |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.