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.
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 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
- metal-flakes
- foreign-body
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.
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