Medical convenience kits recalled due to detachable metal flakes
AVID Medical is recalling Halyard PACEMAKER PK medical convenience kits because sponge forceps and towel clamps may shed loose metal flakes that could enter a patient's surgical site, 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: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—metal flakes 'potentially could detach'—but the product poses risk of harm in surgical settings where foreign bodies are high-consequence. Per the rubric, risk-of-harm products where injury has not yet been reported score 3.
Plain-English summary
AVID Medical, Inc. is recalling Halyard PACEMAKER PK medical convenience kits (Model WKMC120-02, Lot 1601647) distributed nationwide in the United States.
The recall affects sponge forceps and towel clamps included in the kits. These components may shed small loose metal flakes that could detach and enter a patient's surgical site undetected, potentially causing local reactions or foreign body reactions.
No illnesses or injuries related to this issue have been reported to date. Affected healthcare providers and patients should stop using the recalled kits and contact AVID Medical, Inc. for instructions on return or replacement.
The recalled product
- Product
- Halyard PACEMAKER PK - Medical convenience kits Model Number: WKMC120-02
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 56
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: 10809160363638 Lot Number: 1601647
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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