PKG, CANNULA 5.5MM AUTOMATIC VALVE STOP COCK W/O TROCAR, P/N 0250080171. 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: 35499 38198 38758 39650 39650N 40110 40250 43627 44955 44976 45866 46024 46320 46396 46710 46802 47210 47389 47513 47750 47970 48066 48398 48762 48965 49494 49498 49612 49834 50168 50430 50722 50855 50920 51536 52647 52919 53043 53136 53515 53795 53972 55872 58336 58821 59615 60227 60752 62482 64133 64678 64965 65640 67422 67737 68342 69272 71077 75257 75918 76080 76460 76831 76960 77711 78491 79425 82007 82916 83532 83926 85069 85467 85909 86149 86265 86430 86539 86869 87496 89088 89441
- 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, CANNULA 5.5MM AUTOMATIC VALVE STOP COCK W/O TROCAR, P/N 0250080171. 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:
35499 38198 38758 39650 39650N 40110 40250 43627 44955 44976 45866 46024 46320 46396 46710 46802 47210 47389 47513 47750 47970 48066 48398 48762 48965 49494 49498 49612 49834 50168 50430 50722 50855 50920 51536 52647 52919 53043 53136 53515 53795 53972 55872 58336 58821 59615 60227 60752 62482 64133 64678 64965 65640 67422 67737 68342 69272 71077 75257 75918 76080 76460 76831 76960 77711 78491 79425 82007 82916 83532 83926 85069 85467 85909 86149 86265 86430 86539 86869 87496 89088 89441
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0605-2015
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