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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Product Detail

Product Description Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for Hysterosonography. Model Number: 61-2005
Recall Number Z-1782-2014
Classification Class II
Code Info Lot 141525
Product Distributed Qty 1180 units
Reason For Recall Sterility of the device may be compromised due to unsealed pouch

Event Detail

Event Id 68317
Product Type Devices
Status Ongoing
Recalling Firm CooperSurgical, Inc.
City Trumbull
State CT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-05-13
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern 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.
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