FDA-Device2026-09-23Class IPACKAGING DEFECT
Haylard BASIC BIOPSY TRAY (Model PM415) recalled for sterility issues in sodium chloride ampules
What this means
AVID Medical's Haylard BASIC BIOPSY TRAY kits (Model PM415) may contain sodium chloride ampules with quality and sterility concerns. The ampules are subject to a separate recall by Spectra Medical. Affected kits were distributed to hospitals and medical facilities in Illinois, North Carolina, Virginia, and Wyoming.
- Check if your facility received any of the affected kit lots: 1652485, 1656642, 1667835, 1676219, 1682251, or 1691940.
- Do not use kits containing recalled sodium chloride ampule lots AB5002 or AB4003.
- Contact AVID Medical or your supplier for instructions on returning or replacing affected kits.
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
All ages
Illnesses reported
None reported
Sold states
Domestic: IL, NC, VA, WY;
Affected count
240 kits
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
Haylard BASIC BIOPSY TRAY; Model/Item Number (Kit): PM415;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3153-2026More AVID Medical recalls
- FDA-Device2026-09-30Halyard IV START KIT NON-STERILE recalled for open or incomplete applicator seal
- FDA-Device2026-09-23AVID Medical Haylard Continuous Nerve Block Tray recalled for sterility and quality issues
- FDA-Device2026-09-23Halyard IV START KIT NON-STERILE recalled for fungal contamination in applicators
- FDA-Device2026-09-23AVID Medical Haylard biopsy kit recalled for sterility and quality issues with sodium chloride ampules
- FDA-Device2026-09-23AVID Medical Haylard 18G Single Shot EPI Tray recalled for sterility and quality issues
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