Halyard PACK MINOR surgical instrument kits recalled for metal flake contamination
AVID Medical is recalling Halyard PACK MINOR surgical kits due to loose metal flakes that may detach from forceps and towel clamps. These flakes could potentially enter a patient's surgical site, 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: This is an FDA Class II recall describing a risk-of-harm product (metal flakes potentially entering surgical site) where injury has not yet been reported, meeting the rubric criterion for severity level 3.
Plain-English summary
AVID Medical, Inc. is recalling Halyard PACK MINOR medical convenience kits (model VMED018-02) distributed nationwide. The recalled kits contain sponge forceps and towel clamps affected by lot numbers 1581222, 1588583, and 1592111. A total of 174 units were distributed.
The sponge forceps and towel clamps may have small loose metal flakes that could potentially detach from the components. If these metal flakes enter a patient's surgical site undetected, they could cause local reactions or foreign body reactions.
Persons and healthcare facilities in possession of the recalled kits should contact AVID Medical, Inc. for instructions on return, replacement, or proper disposal of the affected products.
The recalled product
- Product
- Halyard PACK, MINOR - Medical convenience kits Model Number: VMED018-02
- Manufacturer
- AVID Medical, Inc.
- Hazard
- 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 (3)
- GTIN: 10809160335086 Lot Number: 1581222
- 1588583
- 1592111
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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