Z-0159-2013 Class II Terminated
FDA device recall Z-0159-2013 was initiated by Progressive Medical Inc on October 28, 2011 and is designated Class II. Reason for recall: The tip of the product could come loose or unravel. The recall status is terminated (terminated October 26, 2012). Affected quantity: 124 boxes.
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