Medical surgical kits recalled due to loose metal flakes
AVID Medical is recalling Halyard TOTAL KNEE surgical kits (Model EUOR002-05) because sponge forceps and towel clamps may shed small metal flakes that could contaminate surgical sites and cause reactions.
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 an FDA Class II recall involving a potential risk of foreign bodies entering a surgical site, which could cause patient harm. No illnesses or injuries have been reported, and the hazard is theoretical based on the product design flaw.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard KIT, TOTAL KNEE (Model EUOR002-05), a medical convenience kit used in surgical procedures. The recall affects 132 units distributed nationwide in the United States with Lot Number 1604669.
Sponge forceps and towel clamps included in these kits may have small loose metal flakes that could potentially detach from the components. If these metal flakes enter a patient's surgical site undetected during use, they may cause local reactions or foreign body reactions.
No illnesses or injuries have been reported in association with this recall. Healthcare facilities and surgical centers should verify whether they have received any affected units with the recalled lot number.
The recalled product
- Product
- Halyard KIT, TOTAL KNEE - Medical convenience kits Model Number: EUOR002-05
- Manufacturer
- AVID Medical, Inc.
- Hazard
- metal-flakes
- 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 (1)
- GTIN: 10809160412930 Lot Number: 1604669
Distribution
Distributed nationwide across the United States.
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