Recall Z-0276-2013 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. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China. The product is used for pushing tissue from the incision or wound during m
| Date | Nov 9, 2012 (initiated Dec 9, 2011) |
| Status | Terminated |
| Reason | Some of the sterile packages had broken seals. |
| Root cause | Packaging |
| Action | Progressive Medical Inc contacted their customers via telephone on December 9, 2011, through December 15, 2011. Customers were informed the reason for recall was explained and the customer was 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 further questions please call (314) 961-5786. |
| Quantity | 70 boxes |
| Distribution | USA (nationwide) including the states of CO, IN, KS, MA, MN, MO, NE, OH, SC, 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.