Surgical forceps and clamps recall due to potential loose metal flakes
AVID Medical is recalling Halyard OR Endovascular Tray surgical kits due to loose metal flakes that could detach from forceps and clamps and potentially enter the surgical site.
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: This is a Class II FDA recall of a surgical device where metal flakes could detach and enter a patient's surgical site, potentially causing local or foreign body reactions. No illnesses or injuries have been reported, making this a risk-of-harm product where injury has not yet been reported.
Plain-English summary
AVID Medical, Inc. is recalling Halyard OR Endovascular TRAY surgical convenience kits (Model SAMM048-15, Lot Numbers 1590860 and 1593416) due to a defect affecting the sponge forceps and towel clamps.
Small loose metal flakes may detach from these components. Metal flakes could potentially enter a patient's surgical site during use, which may cause local reactions or foreign body reactions.
The product was distributed nationwide in the United States.
The recalled product
- Product
- Halyard OR ENDOVASCULAR TRAY - Medical convenience kits Model Number: SAMM048-15
- Manufacturer
- AVID Medical, Inc.
- Hazard
- loose-metal-flakes
- foreign-body-injury
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: 10809160384206 Lot Number: 1590860
- 1593416
Distribution
Distributed nationwide across the United States.
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