Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK...
FDA Recall #Z-0159-2013 — Class II — October 28, 2011
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.
Recalling Firm
Progressive Medical Inc — Saint Louis, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
124 boxes
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated