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U.S. Department of Health and Human Services

Class 2 Device Recall Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm c 40cm)

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  Class 2 Device Recall Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm c 40cm) see related information
Date Initiated by Firm December 09, 2011
Date Posted November 09, 2012
Recall Status1 Terminated 3 on November 14, 2012
Recall Number Z-0276-2013
Recall Event ID 63445
Product Classification Dissector surgical General & Plastic Surgery - Product Code GDI
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.
Code Information Lot 1108-01
Recalling Firm/
Manufacturer		 Progressive Medical Inc
11085 Gravois Industrial Ct
Saint Louis MO 63128-2012
For Additional Information Contact Dean Sullivan
314-961-5786
Manufacturer Reason
for Recall		 Some of the sterile packages had broken seals.
FDA Determined
Cause 2		 Packaging
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.
Quantity in Commerce 70 boxes
Distribution USA (nationwide) including the states of CO, IN, KS, MA, MN, MO, NE, OH, SC, TN, TX, VA, and WI.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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