Z-0159-2013 Class II Terminated

Recalled by Progressive Medical Inc — Saint Louis, MO

Recall Details

Product Type
Devices
Report Date
November 7, 2012
Initiation Date
October 28, 2011
Termination Date
October 26, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
124 boxes

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. 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.

Reason for Recall

The tip of the product could come loose or unravel.

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.

Code Information

Lot 1104-01