Device product
Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10
Z-0453-2025
Product summary
- Event
- Event 95515
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 6 eaches
- Official record key
device-enforcement:Z-0453-2025
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: 10809160335536 Lot Number: 1599244
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Foreign material or chemical contamination
foreign body