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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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Product Detail

Product Description 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.
Recall Number Z-0276-2013
Classification Class II
Code Info Lot 1108-01
Product Distributed Qty 70 boxes
Reason For Recall Some of the sterile packages had broken seals.

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 Telephone
Distribution Pattern USA (nationwide) including the states of CO, IN, KS, MA, MN, MO, NE, OH, SC, TN, TX, VA, and WI.