Z-3154-2026 Class I Ongoing
FDA device recall Z-3154-2026 was initiated by AVID Medical, Inc. on August 10, 2026 and is designated Class I. Reason for recall: Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical. The recall status is ongoing. Affected quantity: 340 kits.
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2026
- Initiation Date
- August 10, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 340 kits
Product Description
Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;
Reason for Recall
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
Distribution Pattern
Domestic: IL, NC, VA, WY;
Code Information
Model/Item Number (Kit): VARV042-03; UDI-DI: 10809160490822; Kit Lots: 1668365, 1668366, 1688166, 1692637, 1696930; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003;