Reported Jun 18, 2014 · Terminated

Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005

CooperSurgical, 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: CooperSurgical, Inc. · 75 Vista Pl · Trumbull, CT · 06611-3934

Is this the product you have?

  • Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography
  • Model Number61-2005
Lot codes and dates
  • Lot 141525
Amount recalled
1180 units

Where it was sold

Why it was recalled

Sterility of the device may be compromised due to unsealed pouch

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 May 28, 2015 · Data as of Sep 19, 6:16 PM UTC

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