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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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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
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.

Product Detail

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