Halyard RAPIDES E-PACK Cardiovascular Kits: Surgical Needle Coating Defect
AVID Medical is recalling Halyard RAPIDES E-PACK Cardiovascular Procedure Kits due to a coating defect on surgical needles that may diminish needle performance during procedures. The defect affects units distributed nationwide in Illinois and Louisiana.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device recall involving a surgical instrument coating defect that could impact clinical performance. No illnesses or injuries have been reported, making this a risk-of-harm scenario without confirmed adverse events, which places it at High (3) per the rubric.
Plain-English summary
AVID Medical, Inc. is recalling Halyard RAPIDES E-PACK Cardiovascular Procedure Convenience Kits due to a defect in the raw material used to coat surgical needles included in these kits. The affected needles may experience diminished performance and/or removal of the silicone needle coating during use.
The kits affected by this recall were distributed nationwide in Illinois and Louisiana. The specific affected lot is Lot Code 1636640 with expiration date 1/13/2028, Model No. RPGH9472-01, UDI 10809160211311. A total of 72 units have been distributed.
Clinical facilities and healthcare providers who have received these kits should discontinue use and contact AVID Medical, Inc. for instructions on return or replacement. No illnesses or injuries have been reported at this time. Adverse events related to this product may be reported to the FDA through their MedWatch program.
The recalled product
- Product
- Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.
- Manufacturer
- AVID Medical, Inc.
- Hazard
- coating-defect
- device-malfunction
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model No. RPGH9472-01
- UDI: 10809160211311
- Lot Code: Lot: 1636640
- Exp: 1/13/2028.
Distribution
Distributed nationwide across the United States.
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