Z-1743-2025 Class II Ongoing
FDA device recall Z-1743-2025 was initiated by AVID Medical, Inc. on March 31, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 72 units.
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
- 72 units
Product Description
Halyard RAPIDES E-PACK. 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. RPGH9472-01; UDI: 10809160211311; Lot Code: Lot: 1636640; Exp: 1/13/2028.