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.
Recall
- Recall Number
- Z-0159-2013
- Event Number
- 62386
- Firm
- Progressive Medical Inc
- FEI Number
- 3000236238
- Product Code
- GDI
- Status
- Terminated
- Root Cause
- Packaging
- Initiated
- October 28, 2011
- Posted
- October 26, 2012
- Terminated
- October 26, 2012
- Address
- 11085 Gravois Industrial Ct, Saint Louis, MO, 63128-2012
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.
The tip of the product could come loose or unravel.
The recalling firm sent a letter dated October 28, 2011 to the customer who reported the problem and calls were initiated 6/26/12 to the remainder of the customers. The reason for recall was explained and the customer were asked if any of the lot remained in their inventory. If inventory remained, the recalling firm sent them a return goods authorization number and informed them the product would be replaced. For questions call 1-800-969-6331.
US Nationwide Distribution in the states of: CO, IL, IN, KS, LA, MA, MN, MO, NE, OH, OK, TN, TX, VA, and WI.
124 boxes