Recall Z-1352-2023— Merit Medical Systems, Inc.
Class II · Ongoing
Class II FDA medical device recall by Merit Medical Systems, Inc., initiated 2023-02-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A. Reason: Product that was built for design verification testing was inadvertently distributed to customers..
- Recalling firm
- Merit Medical Systems, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-02-15
- Firm location
- South Jordan, UT, United States
Product description
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Reason for recall
Product that was built for design verification testing was inadvertently distributed to customers.
Data sourced from openFDA. This site is unofficial and independent of the FDA.