Surgical kits recalled for potentially detachable metal flakes
AVID Medical is recalling Halyard VA lumbar laminectomy surgical kits because sponge forceps and towel clamps may have loose metal flakes that could detach and enter a patient's surgical site.
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: This FDA Class II recall involves a risk of foreign body contamination in a surgical setting with potential for patient harm. However, the source text does not report any illnesses, injuries, or deaths, and the hazard is theoretical (flakes "potentially could detach," "may enter"). Per the severity rubric, risk-of-harm products without reported injury warrant a High (3) rating.
Plain-English summary
AVID Medical, Inc. is recalling Halyard VA LUMBAR LAMINECTOMY medical convenience kits (Model Number VMED009-03) distributed nationwide. The sponge forceps and towel clamps included in these kits contain small loose metal flakes that could potentially detach during surgical use.
If metal flakes detach from the instruments during a lumbar laminectomy procedure, they could enter the patient's surgical site undetected. This could cause local tissue reactions or foreign body reactions that may require additional medical intervention.
Affected kits bear lot numbers 1603129 and 1605478 (GTIN 10809160393918). Healthcare facilities and providers should stop using these kits immediately and contact AVID Medical, Inc. for instructions on return, replacement, or destruction of affected products. Patients who have undergone or are scheduled for lumbar laminectomy procedures should consult their surgeon if they have concerns.
The recalled product
- Product
- Halyard VA LUMBAR LAMINECTOMY - Medical convenience kits Model Number: VMED009-03
- Manufacturer
- AVID Medical, Inc.
- Affected units
- 24
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: 10809160393918 Lot Number: 1603129
- 1605478
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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