AVID Medical Recalls Halyard Surgical Kits Due to Metal Flakes
AVID Medical is recalling Halyard SPECIALS PACK medical convenience kits because sponge forceps and towel clamps may release metal flakes that could enter a patient's surgical site.
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: The recall involves a risk-of-harm product where injury has not yet been reported, specifically the potential for foreign body reactions from metal flakes entering a surgical site.
Plain-English summary
AVID Medical, Inc. is recalling 45 units of Halyard SPECIALS PACK medical convenience kits, model number VAST031-08. The affected units were distributed nationwide in the United States. The recall is associated with GTIN 10809160416310 and Lot Number 1597663.
The recall is being issued because sponge forceps and towel clamps included in the kits may have small loose metal flakes that could detach from the components. If these metal flakes enter a patient's surgical site undetected, they may cause local reactions or possible foreign body reactions.
Healthcare facilities and consumers who have these specific kits should stop using them and contact AVID Medical, Inc. for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Halyard SPECIALS PACK - Medical convenience kits Model Number: VAST031-08
- Manufacturer
- AVID Medical, Inc.
- Hazard
- Affected units
- 45
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 (1)
- GTIN: 10809160416310 Lot Number: 1597663
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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