AVID Medical, Inc.: Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- AVID Medical, Inc.
- Product
- Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;
- Reason / hazard
- Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- Domestic: IL, NC, VA, WY;
- Recall initiated
- 2026-08-10
- Code info
- Model/Item Number (Kit): VARV042-03; UDI-DI: 10809160490822; Kit Lots: 1668365, 1668366, 1688166, 1692637, 1696930; Recalled Sodium Chloride Ampule Lot: AB5002, AB4003;
- Product quantity
- 340 kits
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Toano
- State
- VA
- Country
- United States
- Event id
- 99758
Free daily digest + "My products" watchlist