Reported Sep 7, 2016 · Terminated

Double Pump RF Patient Cassette; Product Number: 72204055. Intended to provide fluid distension and irrigation and…

Medical Vision Ab

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: Medical Vision Ab · Haestholmsvaegen 32 · Nacka, N/A · N/A

Is this the product you have?

  • Double Pump RF Patient Cassette
  • Product Number72204055. Intended to provide fluid distension and irrigation and fluid suction during diagnostic and operative arthroscopic procedures
Lot codes and dates
  • All lot numbers of Double Pump RF Patient Cassettes delivered to the US
  • Batch numbers
    • 13I03
    • 14A01
    • 14A06
    • 14A09
    • 14A10
    • 14B03
    • 14B09
    • 14C06
    • 14C10
    • 14D07
    • 14D11
    • 14E06
    • 14E10
    • 14F01
    • 14F02
    • 14F03
    • 14F04
    • 14F10
    • 14F11
    • 14G07
    • 14H02
    • 14H04
    • 14H08
    • 14H09
    • 14J01
    • 14J02
    • and 14J03
Amount recalled
3,295 devices

Where it was sold

Why it was recalled

Sterility of device may be compromised due to sterile package breakage.

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

Want the full recall guide?

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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 18, 2017 · Data as of Sep 19, 5:21 PM UTC

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