Halyard SAMMC ANGIOGRAPHY Medical Kits Recalled for Loose Metal Flakes
AVID Medical recalls Halyard SAMMC ANGIOGRAPHY medical convenience kits due to loose metal flakes on sponge forceps and towel clamps. Metal flakes may enter surgical sites, potentially causing local reactions or foreign body complications.
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 medical device recall for potential foreign body contamination in surgical sites. No illnesses or injuries reported; the hazard is theoretical based on potential for metal fragments to detach and enter the surgical field.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard SAMMC ANGIOGRAPHY medical convenience kits (Model SAMM066-15) due to manufacturing defects in the included sponge forceps and towel clamps. These components may develop small loose metal flakes on their surfaces.
The metal flakes could potentially detach during a procedure. If metal fragments enter a patient's surgical site undetected, they may cause local reactions or foreign body complications.
Approximately 216 units were distributed nationwide. The affected lot numbers are 1589652 and 1595715 (GTIN: 10809160388495).
The recalled product
- Product
- Halyard SAMMC ANGIOGRAPHY - Medical convenience kits Model Number: SAMM066-15
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 216
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 (2)
- GTIN: 10809160388495 Lot Number: 1589652
- 1595715
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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