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

FDA Device Recall #Z-0159-2013 - Class II, October 28, 2011

Recall Summary

Recall Number Z-0159-2013
Classification Class II - Moderate risk
Date Initiated October 28, 2011
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Progressive Medical Inc
Location Saint Louis, MO
Product Type Devices
Quantity 124 boxes

Product Description

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.

Reason for Recall

The tip of the product could come loose or unravel.

Distribution Pattern

US Nationwide Distribution in the states of: CO, IL, IN, KS, LA, MA, MN, MO, NE, OH, OK, TN, TX, VA, and WI.

Lot / Code Information

Lot 1104-01

Other Recalls from Progressive Medical Inc

Recall # Classification Product Date
Z-1355-2013 Class II Progressive Medical PTFE Coated Disposable Elec... Apr 12, 2013
Z-1357-2013 Class II Progressive Medical PTFE Coated Disposable Elec... Apr 12, 2013
Z-1349-2013 Class II Progressive Medical PTFE Coated Disposable Elec... Apr 12, 2013
Z-1360-2013 Class II Progressive Medical PTFE Coated Disposable Ele... Apr 12, 2013
Z-1364-2013 Class II Progressive Medical PTFE Coated Disposable Elec... Apr 12, 2013

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic, removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency, Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.