FDAFDA · Food and drugs·Recall number Z-0454-2025
Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02
Published November 20, 2024 · Recall initiated: September 20, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- AVID Medical, Inc.
- Distributor
- US Nationwide distribution.
- Lot
- GTIN: 10809160363638 Lot Number: 1601647
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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