Recall Z-0276-2013— Progressive Medical Inc
Class II · Terminated
Class II FDA medical device recall by Progressive Medical Inc, initiated 2011-12-09, terminated 2012-11-14. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: Some of the sterile packages had broken seals..
- Recalling firm
- Progressive Medical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-12-09
- Terminated
- 2012-11-14
- Firm location
- Saint Louis, MO, United States
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. 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.
Reason for recall
Some of the sterile packages had broken seals.
Data sourced from openFDA. This site is unofficial and independent of the FDA.