Official recall notice

FDA DeviceClass INotable

FDA Recall: Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;

Recall date
2026-09-23
FDA class
Class I

Why it was recalled

Hazard

Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.

Product description

Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.

Affected products

Model/Item Number (Kit): VARV042-03; UDI-DI: 10809160490822; Kit Lots: 1668365, 1668366, 1688166, 1692637, 1696930; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003;

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