FDA-Device2026-10-14Class IIPROCESSING DEFECT

AVID Medical Endovascular Pack recalled for manufacturing lubricant contamination

OTHERNationwide distributionMedical devices

What this means

AVID Medical's Endovascular Pack (Model VAPX014-04) may contain residual lubricant from the manufacturing process. The contamination affects specific lot numbers distributed across six U.S. states. No injuries have been reported to date.

  • Check if you have model VAPX014-04 with lot numbers 1701106, 1702175, or 1702273.
  • Contact your AVID Medical representative or the supplier for instructions on return or replacement.
  • Do not use affected kits until you receive guidance from AVID Medical.
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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
33
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
ENDOVASCULAR PACK; Model/Item Number (Kit): VAPX014-04;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0095-2027

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