Official recall notice

FDA DeviceClass IINotable

FDA Recall: Halyard LAVH PACK, Model/Catalog Number: USAR053-11 containing Clearify Visualization System (530390

Recall date
2026-08-26
FDA class
Class II

Why it was recalled

Hazard

The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.

Product description

The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.

Affected products

UDI/DI: 10809160372357, Lot No.: 1669869, Expiration Date: 4/30/2027

Verify with the official notice →
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