PKG, NEEDLE HOLDER, STRIAGHT, P/N 0250080340. 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: 247810 341537 440293 441251 441512 742141 744846 745483 840074 840509 846996 847695 847971 940051 940785 941250 942774 943684 944126 945441 1040422 1042501 1042937 1043498 1045032 1045646 1046195 1140658 1141568 1141927 1142299 1144210 1144626 1145149 1145983 1146678 1240546 1242127 1242255 1242935 1243538 1243953 1245819 1246065 1246178 1341532 1341556 1342750 1343397 1344034 1344462 1345425 1346314 1440438 1440466 1443606
- 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, NEEDLE HOLDER, STRIAGHT, P/N 0250080340. 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:
247810 341537 440293 441251 441512 742141 744846 745483 840074 840509 846996 847695 847971 940051 940785 941250 942774 943684 944126 945441 1040422 1042501 1042937 1043498 1045032 1045646 1046195 1140658 1141568 1141927 1142299 1144210 1144626 1145149 1145983 1146678 1240546 1242127 1242255 1242935 1243538 1243953 1245819 1246065 1246178 1341532 1341556 1342750 1343397 1344034 1344462 1345425 1346314 1440438 1440466 1443606
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0689-2015
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