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PKG, KNOT PUSHER 5MM OPEN, P/N 0250080132 Laparoscopic Manual Instruments are intended for cutti...

FDA Device Recall #Z-0599-2015 — Class II — November 17, 2014

Recall Summary

Recall Number Z-0599-2015
Classification Class II — Moderate risk
Date Initiated November 17, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Stryker Endoscopy
Location San Jose, CA
Product Type Devices
Quantity 180,573 units total

Product Description

PKG, KNOT PUSHER 5MM OPEN, P/N 0250080132 Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

Reason for Recall

The parameters provided in the Laparoscopic Manual Instruments Instructions for Use (IFU 1000-401-070 Revision G or prior) do not support the unwrapped Gravity cycle and the Ethylene Oxide cycle sterilization methods

Distribution Pattern

Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.

Lot / Code Information

443530 940772 941380 942132 942251 1040526 1041289 1042465 1043108 1043109 1043110 1044455 1045026 1046385 1140655 1141210 1141782 1142627 1143074 1143156 1144548 1145353 1146980 1147097 1240543 1242451 1243364 1244180 1246138 1246145 1340556 1341561 1342150 1343019 1343312 1343417 1346108 1346431 1440890 1441386

Other Recalls from Stryker Endoscopy

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Z-1566-2016 Class II PneumoSure XL High Flow Insufflator and Pneumo... Mar 28, 2016
Z-1831-2015 Class II SERFAS 90 degree Energy Probe, Part Number 279-... Jun 3, 2015
Z-0631-2015 Class II PKG, PENNINGTON FORCEPS, P/N 0250080242. Lapa... Nov 17, 2014
Z-0646-2015 Class II PKG, ENDO METZENBAUM SCISSORS, CURVED, P/N 0250... Nov 17, 2014
Z-0679-2015 Class II PKG, ALLIGATOR FORCEPS, P/N 0250080316. Laparo... Nov 17, 2014

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

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.

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