FDA-Device2026-10-14Class IIPROCESSING DEFECT
AVID Medical PACK OPEN HEART CFH recalled for potential manufacturing lubricant contamination
What this means
AVID Medical's PACK OPEN HEART CFH surgical kits (models UFCF004-06 and UFCF004-07) may contain residual lubricant from the manufacturing process. The contamination was identified in specific lot numbers during quality review. No injuries have been reported to date.
- Check if you have an affected kit by matching your model number (UFCF004-06 or UFCF004-07) and lot number to the FDA notice.
- Do not use affected kits; contact AVID Medical for instructions on return or replacement.
- Notify your facility's procurement and surgical teams immediately if you have received an affected lot.
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
124
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
PACK OPEN HEART CFH; Model/Item Number (Kit): 1. UFCF004-06, 2. UFCF004-07;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0097-2027More AVID Medical recalls
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- FDA-Device2026-10-14AVID Medical DAVINCI LAP/GYN surgical kit recalled for manufacturing lubricant contamination
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