Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in

FDA device recall Z-0159-2013 · posted 2012-10-26 · Terminated

Recall details

Recalling firm

Progressive Medical Inc

Reason for recall

The tip of the product could come loose or unravel.

Action taken

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.

Root cause

Packaging

Status

Terminated

Product code

GDI

Quantity affected

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.

Date initiated

2011-10-28

Date posted

2012-10-26

Date terminated

2012-10-26

Location

Saint Louis, MO