Halyard IR Biopsy Pack recalled for loose metal flakes in surgical kit
AVID Medical is recalling Halyard IR BIOPSY PACK due to loose metal flakes in forceps and towel clamps that could detach and enter the surgical site, potentially causing local or foreign body 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: This is an FDA Class II recall involving a risk of foreign body contamination in a surgical site. No illnesses or injuries have been reported. The hazard is potential rather than confirmed, making this a high-risk situation where injury has not yet been reported, warranting a High (3) severity score.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard IR BIOPSY PACK (Model AVMD019-01), a medical convenience kit used in surgical biopsy procedures. The recall involves lot 1583034 distributed nationwide in the United States.
The recall was initiated because the sponge forceps and towel clamps included in the kit contain components with small loose metal flakes. These flakes could potentially detach from the components during surgical use.
If metal flakes detach, they may enter a patient's surgical site without being detected. This could result in local reactions or foreign body reactions in the patient.
The recalled product
- Product
- Halyard IR BIOPSY PACK - Medical convenience kits Model Number: AVMD019-01
- Manufacturer
- AVID Medical, Inc.
- Hazard
- Affected units
- 24
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: 10809160304969 Lot Number: 1583034
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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