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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 x 40cm)

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  Class 2 Device Recall Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm) see related information
Date Initiated by Firm October 28, 2011
Date Posted October 26, 2012
Recall Status1 Terminated 3 on October 26, 2012
Recall Number Z-0159-2013
Recall Event ID 62386
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.

Product Usage:
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 1104-01
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		 The tip of the product could come loose or unravel.
FDA Determined
Cause 2		 Packaging
Action The recalling firm sent a letter dated October 28, 2011 to the customer who reported the problem and calls were initiated 6/26/12 to the remainder of the customers. The reason for recall was explained and the customer were 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 questions call 1-800-969-6331.
Quantity in Commerce 124 boxes
Distribution US Nationwide Distribution in the states of: CO, IL, IN, KS, LA, MA, MN, MO, NE, OH, OK, 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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