FDA-Device2026-09-23Class IPACKAGING DEFECT
AVID Medical Haylard biopsy kit recalled for sterility and quality issues with sodium chloride ampules
What this means
AVID Medical's Haylard Universal Imaging Biopsy kit (model VARV042-03) contains sodium chloride ampules that may have quality and sterility problems. The ampules are subject to a separate recall by Spectra Medical. Affected kits were distributed in Illinois, North Carolina, Virginia, and Wyoming.
- Check if you have kit model VARV042-03 with lot numbers 1668365, 1668366, 1688166, 1692637, or 1696930
- Do not use kits containing sodium chloride ampule lots AB5002 or AB4003
- Contact AVID Medical or your supplier for instructions on return or replacement
The agency's original wording
Hazard
Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
Intended for
Adults
Illnesses reported
None reported
Sold states
Domestic: IL, NC, VA, WY;
Affected count
340 kits
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3154-2026More AVID Medical recalls
- FDA-Device2026-09-23AVID Medical Haylard 18G Single Shot EPI Tray recalled for sterility and quality issues
- FDA-Device2026-09-09AVID Medical neurological surgical kits recalled for endotoxin variability in sponges
- FDA-Device2026-09-09Halyard medical convenience kits recalled for neurological sponges with inconsistent endotoxin levels
- FDA-Device2026-09-09Halyard medical surgical kits recalled for neurological sponges with variable endotoxin levels
- FDA-Device2026-07-29Halyard EYE PACK convenience kit recalled for incorrect Betadine solution concentration
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