AVID Medical Recalls Pacemaker Convenience Kits Due to Metal Flakes
AVID Medical, Inc. is recalling Halyard SAMMC-N pacemaker convenience kits because sponge forceps and towel clamps may shed 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 (medical device) where injury has not yet been reported, fitting the 'High' severity criteria for potential harm without confirmed illness or injury.
Plain-English summary
AVID Medical, Inc. is recalling 33 units of Halyard SAMMC-N Pacemaker Medical Convenience Kits, Model Number SAMM065-10. The affected lots are 1586050, 1586407, and 1605747, and the products were distributed nationwide in the United States.
The recall was initiated 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 providers and facilities should stop using the affected kits and contact AVID Medical, Inc. for instructions on how to return or dispose of the products.
The recalled product
- Product
- Halyard SAMMC-N PACEMAKER - Medical convenience kits Model Number: SAMM065-10
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 33
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 (3)
- GTIN: 10809160370186 Lot Number: 1586050
- 1586407
- 1605747
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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