FDAFDA · Food and drugs·Recall number Z-0276-2013
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.
Published November 21, 2012 · Recall initiated: December 9, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Some of the sterile packages had broken seals.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Progressive Medical Inc
- Distributor
- USA (nationwide) including the states of CO, IN, KS, MA, MN, MO, NE, OH, SC, TN, TX, VA, and WI.
- Lot
- Lot 1108-01
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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