FDA-Device2026-10-14Class IIPROCESSING DEFECT

AVID Medical robotic prostatectomy pack recalled for potential lubricant contamination

OTHERNationwide distributionMedical devices

What this means

AVID Medical's robotic prostatectomy pack (Model NAMC423-11) may contain residual lubricant from the manufacturing process. This contamination could affect the sterility and safety of the surgical kit. Six units have been identified and recalled.

  • Contact your hospital or surgical facility immediately if you received or used this kit.
  • Do not use the affected kit (Model NAMC423-11, Lot 1671502) for any procedures.
  • Report any adverse events or concerns to AVID Medical or the FDA MedWatch program.
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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
6
Manufactured in
9000 Westmont Dr, N/A, Toano, VA, United States
Products
ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0098-2027

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