Medical Surgical Kit Recalled for Potential Loose Metal Flake Hazard
AVID Medical recalls Halyard D & C surgical convenience kits due to potential metal flakes that could detach from forceps and clamps. Affected lot 1596759 was 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: FDA Class II recall of surgical instruments with potential for foreign body contamination in surgical sites. No illnesses or injuries have been reported in the source. This represents a risk-of-harm scenario without confirmed injury, classified as High per the rubric.
Plain-English summary
AVID Medical, Inc. is recalling Halyard D & C PACK-CKC medical convenience kits (model BMGT003-02, lot number 1596759) distributed nationwide. The recall affects surgical instruments included in these kits.
The sponge forceps and towel clamps in these kits may develop small loose metal flakes that could detach during use and enter a patient's surgical site. Once in the surgical site, these metal flakes may cause local reactions or foreign body reactions.
Healthcare facilities and providers using this lot should cease use and contact the manufacturer for guidance.
The recalled product
- Product
- Halyard D & C PACK-CKC - Medical convenience kits Model Number: BMGT003-02
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device
- Hazard
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: 10809160392027 Lot Number: 1596759
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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