Recall Z-0159-2013 ยท GDI Dissector, Surgical, General & Plastic Surgery
Progressive Medical Inc
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 laparoscop
| Date | Oct 26, 2012 (initiated Oct 28, 2011) |
| Status | Terminated |
| Reason | The tip of the product could come loose or unravel. |
| Root cause | Packaging |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.