Reported Sep 3, 2014 · Terminated

CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number…

Civco Medical Instruments Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Civco Medical Instruments Inc · 102 1st St S · Kalona, IA · 52247-9589

Is this the product you have?

  • CollectEVAC, Sterile device with tubing and adaptor for use with ACMI and STORZ/Wolf resectoscopes. Part number 610-954. Rx only. Sterile EO. The product is intended to be used to perform irrigation, tissue collection, and/or straining functions during transurethral prostate or bladder surgery.
Lot codes and dates
  • Lot numbers
    • M431760
    • M431710
    • M426580
    • M430200
    • M423010
Amount recalled
52 kits

Where it was sold

Why it was recalled

A pinhole leak identified in the packaging of the recalled product potentially could compromise the sterility of the product.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jan 28, 2015 · Data as of Sep 19, 6:47 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.