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.
FDA Recall Z-0276-2013 · Posted 2012-11-09
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Recalling FirmProgressive Medical Inc
Recall StatusTerminated
Product CodeGDI
Date Initiated2011-12-09
Date Terminated2012-11-14
Product Quantity70 boxes
Reason for Recall
Some of the sterile packages had broken seals.
Firm 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.
Root Cause
Packaging
Distribution Pattern
USA (nationwide) including the states of CO, IN, KS, MA, MN, MO, NE, OH, SC, TN, TX, VA, and WI.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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