Reported Oct 14, 2015 · Terminated

CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061

CooperSurgical, Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

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: CooperSurgical, Inc. · 75 Corporate Dr · Trumbull, CT · 06611-1350

Is this the product you have?

  • CooperSurgical LEEP REDIKIT-Used as a surgical preparatory kit for Loop Electrosurgical Excision Procedure P/N 6061
Lot codes and dates
  • LOT 187889
Amount recalled
305 units

Where it was sold

Why it was recalled

Kit Label incorrect :Labeled with Lidocaine HCI drug cartridges Lidocaine HCl (2%) but contains vials Lidocaine HCl (1%)

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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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 29, 2016 · Data as of Sep 19, 6:01 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.