Home / Recalls / Progressive Medical Inc / Z-0276-2013

Z-0276-2013 Class II Terminated

Recalled by Progressive Medical Inc — Saint Louis, MO

Recall Details

Product Type
Devices
Report Date
November 21, 2012
Initiation Date
December 9, 2011
Termination Date
November 14, 2012
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
70 boxes

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.

Distribution Pattern

USA (nationwide) including the states of CO, IN, KS, MA, MN, MO, NE, OH, SC, TN, TX, VA, and WI.

Code Information

Lot 1108-01

Other recalls by Progressive Medical Inc

  • Z-1355-2013 Class II — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -Laparosco (April 12, 2013)
  • Z-1360-2013 Class II — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparos (April 12, 2013)
  • Z-1356-2013 Class II — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes -NON-STICK (April 12, 2013)
  • Z-1350-2013 Class II — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparosc (April 12, 2013)
  • Z-1361-2013 Class II — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STIC (April 12, 2013)
  • Z-1357-2013 Class II — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparosc (April 12, 2013)
  • Z-1363-2013 Class II — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparosc (April 12, 2013)
  • Z-1353-2013 Class II — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparosc (April 12, 2013)
  • Z-1359-2013 Class II — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparosc (April 12, 2013)
  • Z-1358-2013 Class II — Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - Laparosc (April 12, 2013)