Surgical forceps and clamps recalled due to potential metal flake contamination
AVID Medical is recalling Halyard ENT surgical convenience kits due to potential metal flakes from forceps and clamps that could enter a patient's surgical site. Metal flakes may cause local or foreign body reactions during surgery.
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 of surgical instruments with potential for patient harm. The hazard—loose metal flakes that could contaminate surgical sites and cause local or foreign body reactions—represents a significant risk of harm to patients undergoing procedures with these instruments, though no illnesses or injuries have been reported to date.
Plain-English summary
AVID Medical, Inc. is recalling Halyard ENT Medical convenience kits (Model VMED011-01) nationwide. The kits contain sponge forceps and towel clamps that may have small loose metal flakes.
The metal flakes could potentially detach from the forceps and clamps during use and enter a patient's surgical site undetected. If metal flakes enter the surgical site, they may cause local tissue reactions or foreign body reactions.
The recalled product
- Product
- Halyard ENT - Medical convenience kits Model Number: VMED011-01
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 21
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: 10809160334980 Lot Number: 1582596
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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