Halyard Pacemaker Pack surgical kits recalled for loose metal flakes
AVID Medical is recalling Halyard Pacemaker Pack surgical kits because sponge forceps and towel clamps contain loose metal flakes that could detach and enter patient surgical sites.
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 of surgical instruments with risk-of-harm from potential foreign body contamination. No illnesses or injuries have been reported. This fits the rubric criterion: risk-of-harm products where injury has not yet been reported.
Plain-English summary
AVID Medical, Inc. is recalling Halyard Pacemaker Pack medical convenience kits (Model MAMC223-08, Lot 1572713) due to loose metal flakes on sponge forceps and towel clamps included in the kits.
These metal flakes can detach from the components and potentially enter a patient's surgical site undetected, causing local reactions or possible foreign body reactions.
The kits were distributed nationwide.
The recalled product
- Product
- Halyard PACEMAKER PACK - Medical convenience kits Model Number: MAMC223-08
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 12
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: 10809160316481 Lot Number: 1572713
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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