Reported Dec 28, 2016 · Terminated

Best Practices kits containing certain production lots of Clearify Visualization System Item Code: 21-345 Intended to…

Medtronic

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: Medtronic · 60 Middletown Ave · North Haven, CT · 06473-3908

Is this the product you have?

  • Best Practices kits containing certain production lots of
  • Clearify Visualization System Item Code21-345 Intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope as well as clean the scope lens
Lot codes and dates
  • Kit Parent Codes
    • 00Z2224
    • 00Z2232
    • 00Z2298
    • 00Z2363
    • 00Z2364
    • 00Z2365
    • 00Z2366
    • 00Z2421
    • 00Z2425
    • 00Z2430
    • 00Z2431
    • 00Z2460
    • 00Z2493
    • 00Z2534
    • 00Z2535
    • 000Z2544
    • 00Z5000B
    • 00Z5001B
    • GYNKIT2
Amount recalled
230 systems

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Where it was sold

  • Nationwide

Why it was recalled

Product sterility is compromised due to breach of the sterile barrier

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 Aug 8, 2018 · Data as of Sep 19, 4:45 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.