Surgical instruments recalled for loose metal flake contamination risk
AVID Medical is recalling Halyard RAD PACK medical convenience kits containing sponge forceps and towel clamps. Small metal flakes may detach and enter surgical sites, potentially causing foreign body or local tissue reactions.
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: FDA Class II recall of surgical instruments with loose metal flakes that could enter surgical sites and cause foreign body reactions. No illnesses or injuries reported, but the risk of harm is inherent to the defect.
Plain-English summary
AVID Medical, Inc. is recalling Halyard RAD PACK Model VANW017-04 medical convenience kits distributed nationwide. These kits contain sponge forceps and towel clamps with small loose metal flakes.
The loose metal flakes may detach from the forceps and towel clamps. If these metal flakes enter a patient's surgical site undetected, they could cause local reactions or foreign body reactions.
The recall involves lot number 1603839. No illnesses or injuries have been reported in association with this issue.
The recalled product
- Product
- Halyard RAD PACK - Medical convenience kits Model Number: VANW017-04
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 44
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: 10809160332733 Lot Number: 1603839
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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