Device product
MEDLINE 111 GRAVITY SET W/3 Needle Free Y-Sites REF DYNDTN0555 Catalog Number: SAM2461 UDI code: N/A Engineering Sample/Not for Human Use
Z-2654-2026
Product summary
- Event
- Event 99085
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 50 devices
- Official record key
device-enforcement:Z-2654-2026
Official wording
Reason: Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.
Code information: Catalog Number: SAM2461 REF: DYNDTN0555 UDI code: N/A Lot Number: 25X445
Distribution pattern: U.S.: IL O.U.S: N/A
Derived failure modes
-
Unknown
Due to engineering sample labeled "Not for Human Use" being inadvertently shipped it the U.S. market.