Z-1742-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 21, 2025
- Initiation Date
- March 31, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 units
Product Description
Halyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
Reason for Recall
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
Distribution Pattern
US Nationwide distribution in the states of IL & LA.
Code Information
Model No. SILV800-01; UDI: 10809160450680; Lot Code: Lot: 1642454; Exp: 2/4/2028.