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U.S. Department of Health and Human Services

Enforcement Report - Week of November 7, 2012

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Event Detail

Event ID 62386
Product Type Devices
Status Terminated
Recalling Firm Progressive Medical Inc
City Saint Louis
State MO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-10-28
Initial Firm Notification of
Consignee or Public
Distribution Pattern US Nationwide Distribution in the states of: CO, IL, IN, KS, LA, MA, MN, MO, NE, OH, OK, TN, TX, VA, and WI.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Product Usage: The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures. Lot 1104-01 Class II The tip of the product could come loose or unravel. 124 boxes Z-0159-2013