Z-0434-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2024
- Initiation Date
- September 20, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 eaches
Product Description
Halyard CPT EP PACK - Medical convenience kits Model Number: SHAN442-04
Reason for Recall
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
Distribution Pattern
US Nationwide distribution.
Code Information
GTIN: 10809160413470 Lot Number: 1608261