Haylard Univ Imaging Biopsy Trucustom recall: Sterility Concern
Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;
Why was Haylard Univ Imaging Biopsy Trucustom recalled?
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model/Item Number (Kit): VARV042-03; UDI-DI: 10809160490822; Kit Lots: 1668365, 1668366, 1688166, 1692637, 1696930; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003;
- Product
- Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;
- Recalling firm
- AVID Medical, Inc.
- Quantity
- 340 kits
- Distribution
- Domestic: IL, NC, VA, WY;
- Recall date
- September 23, 2026
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)