Device product
Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.
Z-1743-2025
Product summary
- Event
- Event 96731
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 72 units
- Official record key
device-enforcement:Z-1743-2025
Official wording
Reason: 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.
Code information: Model No. RPGH9472-01; UDI: 10809160211311; Lot Code: Lot: 1636640; Exp: 1/13/2028.
Distribution pattern: US Nationwide distribution in the states of IL & LA.
Derived failure modes
-
Unknown
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.