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.
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 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
- Hazard
- foreign-body-hazard
- metal-fragments
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.
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