FDAClass IIJune 18, 2014

Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended recall: Sterility Concern

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

Why was Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended recalled?

Sterility of the device may be compromised due to unsealed pouch

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 141525

Product
Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
Recalling firm
CooperSurgical, Inc.
Quantity
1180 units
Distribution
Distributed USA (nationwide) including the states of CO, CT, MO, VT, NY, OH, NJ, FL, NC, VA, AL, MA, PA, and CA, and the country of Canada.
Recall date
June 18, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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