FDA-Device2026-10-14Class IIPROCESSING DEFECT
AVID Medical HEART PREP TRAY recalled for potential manufacturing lubricant contamination
What this means
AVID Medical's HEART PREP TRAY (Model MECV97W) may contain residual lubricant from the manufacturing process. The contamination was discovered in specific kit lot numbers and affects a limited quantity distributed across six U.S. states.
- Check if you have kit lot numbers 1691836 or 1696316.
- Contact your supplier or AVID Medical for instructions on return or replacement.
- Do not use affected kits until you receive guidance from the manufacturer.
The agency's original wording
Hazard
Product may be potentially contaminated with a lubricant used during the manufacturing process.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.
Affected count
96
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
HEART PREP TRAY; Model/Item Number (Kit): MECV97W;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0102-2027More AVID Medical recalls
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