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.
What this means for you
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.
- Hazard
- metal-fragment
- foreign-body
- surgical-site-contamination
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.
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