FDA Device recall Z-0453-2025
Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10
- FDA Device
- Class II
- ongoing
- Published 2024-11-20
On 2024-11-20 the FDA classified a Class II recall of Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10 by Avid Medical, citing 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 sit….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0453-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-20 |
| Published | 2024-11-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Avid Medical |
| Distribution | US |
Product
Halyard PACEMAKER TRAY - Medical convenience kits Model Number: VMPB0003-10
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
Identifiers
| code_info | GTIN: 10809160335536 Lot Number: 1599244 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0453-2025%22
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