PKG, 5MM INSULATED SHAFT 33CM, FOR BIPOLAR FORCEPS, P/N 0250080371. 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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 614716 714937 715668 715791 814961 816593 817443 817444 913326 913523 913761 913764 913951 913952 914226 914227 915061 1013608 1014813 1015780 1016062 1016400 1016825 1016827 1113018 1113019 1113020 1113339 1114541 1114542 1114543 1114795 1114796 1115296 1115297 1115651 1116119 1116258 1117011 1117012 1213123 1213124 1213125 1213731 1213732 1213978 1213979 1215123 1215124 1215125 1216148 1216149 1216234 1313047 1313943 1313944 1313945 1314475 1314476 1314696 1316718 1316803 1316804 1316805 1410179 1410180 1410181 1410182 1410415 1410416
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Stryker Endoscopy
- 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
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
PKG, 5MM INSULATED SHAFT 33CM, FOR BIPOLAR FORCEPS, P/N 0250080371. 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.
Product Codes/Lot Numbers:
614716 714937 715668 715791 814961 816593 817443 817444 913326 913523 913761 913764 913951 913952 914226 914227 915061 1013608 1014813 1015780 1016062 1016400 1016825 1016827 1113018 1113019 1113020 1113339 1114541 1114542 1114543 1114795 1114796 1115296 1115297 1115651 1116119 1116258 1117011 1117012 1213123 1213124 1213125 1213731 1213732 1213978 1213979 1215123 1215124 1215125 1216148 1216149 1216234 1313047 1313943 1313944 1313945 1314475 1314476 1314696 1316718 1316803 1316804 1316805 1410179 1410180 1410181 1410182 1410415 1410416
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0698-2015
Related Recalls
When operating the device in high flow mode (40L/min, 15 mmHg) and connecting to a house gas inlet source, within seconds of insufflating the flow rate would drop to 0L/min and the red Check Gas Supply symbol would appear on the display, immediately suspending insufflation.
Stryker Endoscopy is recalling all non expired SERFAS 90 degree Energy Probes due to reports of fragments of the probe breaking off into the patient.
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