Device product
Flex-Neck Catheter External Repair Kit REF CE-1400 LOT CE-1400/A
Z-1352-2023
Product summary
- Event
- Event 91852
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 17 devices
- Official record key
device-enforcement:Z-1352-2023
Official wording
Reason: Product that was built for design verification testing was inadvertently distributed to customers.
Code information: Catalog Number: CE-1400/A UDI-DI Code: 00884450170069 Lot Number: H2586496
Distribution pattern: U.S. Nationwide distribution in the states of MD, MI, OH, and TX. O.U.S.: N/A
Derived failure modes
-
Unknown
Product that was built for design verification testing was inadvertently distributed to customers.