PKG, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 0250080231. 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: 141317 142334 246391 341054 341055 04102012E 540683 540685 0541433D 0541434D 6172014 0640767D 0644142D 0647413D 0647616D 0742463D 0743206D 0744706D 0745084D 0746367D 0747892D 08152012E 08426254D 0845326D 0845889D 0846254D 0847431D 0940080D 0940786D 0942136D 0944434D 0944806D 0945985D 1040597D 1040799D 1041469D 1042944D 1043499D 1143128D 1145076D 1145982D 1147040D 1245448 1245519 1245737 1246194 1246197 1341543 1341543D 1341568 1341568D 1344132 1344132D 1344679 13446790 1344679D 1345511 1442519
- 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, ROTATING HANDLE, RATCHET, INSULATED SHAFT, P/N 0250080231. 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:
141317 142334 246391 341054 341055 04102012E 540683 540685 0541433D 0541434D 6172014 0640767D 0644142D 0647413D 0647616D 0742463D 0743206D 0744706D 0745084D 0746367D 0747892D 08152012E 08426254D 0845326D 0845889D 0846254D 0847431D 0940080D 0940786D 0942136D 0944434D 0944806D 0945985D 1040597D 1040799D 1041469D 1042944D 1043499D 1143128D 1145076D 1145982D 1147040D 1245448 1245519 1245737 1246194 1246197 1341543 1341543D 1341568 1341568D 1344132 1344132D 1344679 13446790 1344679D 1345511 1442519
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0622-2015
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