Halyard RAPIDES E-PACK Cardiovascular Procedure Kit Surgical Needle Coating Issue
AVID Medical is recalling Halyard RAPIDES E-PACK Cardiovascular Procedure Convenience Kits due to a raw material defect in surgical needle coating that may cause diminished performance or coating removal during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 surgical needles used in cardiovascular procedures. The defect—potential coating loss or diminished performance—poses a direct risk of harm during an invasive procedure, even though no reported illnesses or injuries are stated in the source.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard RAPIDES E-PACK Cardiovascular Procedure Convenience Kit (Model No. RPGH9472-01) due to an issue with a raw material used to coat some surgical needles. This coating defect may result in diminished needle performance and/or removal of silicone needle coating during surgical use.
The affected product was distributed nationwide in Illinois and Louisiana. The recalled units include Lot 1636640 with an expiration date of January 13, 2028 (UDI: 10809160211311).
Healthcare providers and patients who have received or used this product should contact AVID Medical, Inc. for further guidance regarding return or replacement of affected kits. If you have questions about whether your product is affected, refer to the lot code and model number on the packaging.
The recalled product
- Product
- Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 72
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
Part of a larger recall action
This product is one of 3 recalled by AVID Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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