AVID Medical Recalls Halyard LAVH PACK Due to Sterilization Error
AVID Medical, Inc. is recalling 40 packs of Halyard LAVH PACK kits because a component was improperly sterilized, potentially causing leaks.
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: The recall involves a medical device where a manufacturing error (improper sterilization) may have led to a component leaking. This represents a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
AVID Medical, Inc. is recalling 40 packs of the Halyard LAVH PACK, Model/Catalog Number USAR053-11, which contains the Clearify Visualization System (5303907). The affected units have UDI/DI 10809160372357, Lot No. 1669869, and an expiration date of 4/30/2027. These products were distributed nationwide in the state of Texas.
The recall was initiated because a kit component was subjected to ethylene oxide (EO) sterilization, which contradicts the manufacturer's recommendations. This deviation from the recommended sterilization process may have led to the component leaking within the kit.
Healthcare providers and consumers should stop using the affected Halyard LAVH PACK kits immediately. Users should contact AVID Medical, Inc. for further instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (5303907).
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 40
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)
- UDI/DI: 10809160372357
- Lot No.: 1669869
- Expiration Date: 4/30/2027
Distribution
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