Z-0159-2013Class II

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

Name: Z-0159-2013 Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product...
Creator: Progressive Medical Inc
Published: 2011-10-28
License: https://open.fda.gov/license/

Progressive Medical Inc / initiated 2011-10-28 / Terminated / root cause: packaging

FDA source

Progressive Medical Inc began a recall of Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip -... on 2011-10-28. FDA classified it as Class II and gives the reason as "The tip of the product could come loose or unravel". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0159-2013
Classification: Class II
Status: Terminated
Initiated: 2011-10-28
Posted: 2012-10-26
Terminated: 2012-10-26
Recalling firm: Progressive Medical Inc
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.
Product code: GDI Dissector, Surgical, General & Plastic Surgery
Reason for recall: The tip of the product could come loose or unravel.
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: Lot 1104-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0159-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0159-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-07	2012-10-26

Product code GDI

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)