Halyard ANGIO PACK surgical kits recalled for loose metal fragments
AVID Medical recalls Halyard ANGIO PACK surgical kits due to loose metal flakes that could detach and enter a patient's surgical site. The recall affects 284 units distributed nationwide.
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 an FDA Class II recall involving surgical instruments with potential risk of metal fragments entering a surgical site and causing local or foreign body reactions. No illnesses or injuries have been reported. Per the severity rubric, this qualifies as High: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
AVID Medical, Inc. is recalling Halyard ANGIO PACK surgical convenience kits (Model WRNM047-05) due to a defect affecting sponge forceps and towel clamps included in the kits.
The recalled kits may contain loose metal flakes that could potentially detach from the components during surgical use. If these metal flakes enter a patient's surgical site undetected, they could cause local reactions or foreign body reactions.
The recall affects 284 units with lot numbers 1585441, 1602960, and 1606379 that were distributed nationwide in the United States.
If you have received or used these kits, discontinue use immediately. Contact AVID Medical for instructions on returning the recalled products or obtaining a replacement.
The recalled product
- Product
- Halyard ANGIO PACK - Medical convenience kits Model Number: WRNM047-05
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Affected units
- 284
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 (3)
- GTIN: 10809160374122 Lot Number: 1585441
- 1602960
- 1606379
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 73 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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