Z-1352-2023 Class II Ongoing
FDA device recall Z-1352-2023 was initiated by Merit Medical Systems, Inc. on February 15, 2023 and is designated Class II. Reason for recall: Product that was built for design verification testing was inadvertently distributed to customers. The recall status is ongoing. Affected quantity: 17 devices.
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2023
- Initiation Date
- February 15, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 devices
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.
Distribution Pattern
U.S. Nationwide distribution in the states of MD, MI, OH, and TX. O.U.S.: N/A
Code Information
Catalog Number: CE-1400/A UDI-DI Code: 00884450170069 Lot Number: H2586496