PKG, 5MM PEEK HANDLE, 45CM, P/N 0250181164 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: 01292013D 0247065C 0341845C 0342941C 0345124C 0345125C 4082014 0540391C 0540392CD 0542893D 0647218D 07122013E 0743480D 0744062D 0843047D 0845027D 0845859D 0846783D 0940144D 0940148D 0940821D 0941601D 0943110D 0943251D 0943541D 0944721D 0945231D 0945465D 1040630D 1040806D 1041063D 1041468D 1042102D 1043037D 1043039D 1044650D 1045037D 1045055D 1045227D 1045481D 1045638D 1045841D 1046702D 11082010A 1141562 1141562D 1141969D 1141970D 1142168D 1143113D 1143150D 1144236D 1144341D 1144655D 1145341D 1145632D 1145809D 1145939 1145939D 1146669D 1146671D 12122013 1241797D 1241938D 1243268D 1243269D 1244956 1244956D 1245522 1245798 1245799 1245799H 1245800 1245977 1340938 1341257 1341872 1343540 1343540H 1343541 1343542 1344000 1344000H 1344251 1440346 1440346H 1440347 1440347H 1440792 1442304 1442799
- 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 PEEK HANDLE, 45CM, P/N 0250181164 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:
01292013D 0247065C 0341845C 0342941C 0345124C 0345125C 4082014 0540391C 0540392CD 0542893D 0647218D 07122013E 0743480D 0744062D 0843047D 0845027D 0845859D 0846783D 0940144D 0940148D 0940821D 0941601D 0943110D 0943251D 0943541D 0944721D 0945231D 0945465D 1040630D 1040806D 1041063D 1041468D 1042102D 1043037D 1043039D 1044650D 1045037D 1045055D 1045227D 1045481D 1045638D 1045841D 1046702D 11082010A 1141562 1141562D 1141969D 1141970D 1142168D 1143113D 1143150D 1144236D 1144341D 1144655D 1145341D 1145632D 1145809D 1145939 1145939D 1146669D 1146671D 12122013 1241797D 1241938D 1243268D 1243269D 1244956 1244956D 1245522 1245798 1245799 1245799H 1245800 1245977 1340938 1341257 1341872 1343540 1343540H 1343541 1343542 1344000 1344000H 1344251 1440346 1440346H 1440347 1440347H 1440792 1442304 1442799
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0757-2015
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