Device product
Halyard EXTREMITY PACK - Medical convenience kits Model Number: MMOK009-03
Z-0416-2025
Product summary
- Event
- Event 95515
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 62 eaches
- Official record key
device-enforcement:Z-0416-2025
Official wording
Reason: Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Metal flakes on components may enter a patients surgical site undetected causing local reactions or possible foreign body reactions
Code information: GTIN: 10809160404188 Lot Number: 1589527
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Foreign material or chemical contamination
foreign body