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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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Event Detail

Event ID 63445
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 2011-12-09
Initial Firm Notification of
Consignee or Public
Distribution Pattern USA (nationwide) including the states of CO, IN, KS, MA, MN, MO, NE, OH, SC, 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. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China. 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 1108-01 Class II Some of the sterile packages had broken seals. 70 boxes Z-0276-2013