Recall Z-1743-2025— AVID Medical, Inc.
Class II · Ongoing
Class II FDA medical device recall by AVID Medical, Inc., initiated 2025-03-31. FDA's recall record names no specific 510(k) clearance for this event. Product: Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.. 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..
- Recalling firm
- AVID Medical, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-03-31
- Firm location
- Toano, VA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.