Halyard surgical kit recalled for loose metal flakes in forceps and clamps
AVID Medical is recalling Halyard KIT, SPINE surgical convenience kits due to loose metal flakes on sponge forceps and towel clamps. The flakes could detach and enter a patient's surgical site, potentially causing local or foreign body reactions.
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 recall of a surgical instrument kit where loose metal flakes could detach and enter a patient's surgical site, creating risk of local or foreign body reactions. No illnesses or injuries have been reported, so per the rubric this scores as High (3) for risk-of-harm products where injury has not yet been reported.
Plain-English summary
AVID Medical, Inc. is recalling the Halyard KIT, SPINE (Model Number EUOR004-03), a medical convenience kit used in surgical settings. The recall affects 174 units distributed nationwide.
The sponge forceps and towel clamps included in these kits may have small loose metal flakes that could detach from the components. These flakes could enter a patient's surgical site undetected during a procedure.
Metal flakes in the surgical site may cause local reactions or foreign body reactions, posing a risk to patient safety. While no injuries have been reported to date, the potential for harm to patients undergoing surgery warrants this recall.
Healthcare facilities and surgical centers using this kit should stop using it immediately and contact AVID Medical for further instructions regarding replacement or return.
The recalled product
- Product
- Halyard KIT, SPINE - Medical convenience kits Model Number: EUOR004-03
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 174
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: 10809160426463 Lot Number: 1597676
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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