Device product
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 medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.
Z-0276-2013
Product summary
- Event
- Event 63445
- Status
- Terminated
- Classification
- Class II
- Quantity
- 70 boxes
- Official record key
device-enforcement:Z-0276-2013
Official wording
Reason: Some of the sterile packages had broken seals.
Code information: Lot 1108-01
Distribution pattern: USA (nationwide) including the states of CO, IN, KS, MA, MN, MO, NE, OH, SC, TN, TX, VA, and WI.
Derived failure modes
-
Unknown
Some of the sterile packages had broken seals.