PKG, CLAW FORCEPS, P/N 0250080244. 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: 542920 744855 745487 747207 842094 846779 847453 940070 940790 942064 942847 943550 944301 945449 1040412 1042233 1042680 1042689 1042701 1045852 1046704 1141030 1141031 1142001 1142002 1144327 1144623 1145082 1145339 1145978 1146685 1146993 1147101 1240120 1240538 1240539 1241480 1241481 1242392 1242393 1242923 1242924 1244171 1244172 1245446 1245447 1246063 1246064 1341588 1341589 1341590 1343694 1346228 1346669 1440891
- 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, CLAW FORCEPS, P/N 0250080244. 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:
542920 744855 745487 747207 842094 846779 847453 940070 940790 942064 942847 943550 944301 945449 1040412 1042233 1042680 1042689 1042701 1045852 1046704 1141030 1141031 1142001 1142002 1144327 1144623 1145082 1145339 1145978 1146685 1146993 1147101 1240120 1240538 1240539 1241480 1241481 1242392 1242393 1242923 1242924 1244171 1244172 1245446 1245447 1246063 1246064 1341588 1341589 1341590 1343694 1346228 1346669 1440891
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0632-2015
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