PKG, GRASPER FORCEPS, SERRATED, P/N 0250080286. 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: 246416 340639 344735 542132 544416 742144 841812 842091 845858 847684 940079 942282 943532 944666 944831 945443 1040391 1040415 1041478 1042250 1042663 1042664 1042665 1042669 1042677 1143123 1144211 1145077 1145684 1146119 1147041 1240547 1241427 1242129 1242645 1243802 1243954 1244189 1245024 1245604 1246054 1246180 1343405 1343556 1344028 1344292 1344459 1345527 1346103 1346649 1440443 1441169 1442254 1442805 645372
- 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, GRASPER FORCEPS, SERRATED, P/N 0250080286. 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:
246416 340639 344735 542132 544416 742144 841812 842091 845858 847684 940079 942282 943532 944666 944831 945443 1040391 1040415 1041478 1042250 1042663 1042664 1042665 1042669 1042677 1143123 1144211 1145077 1145684 1146119 1147041 1240547 1241427 1242129 1242645 1243802 1243954 1244189 1245024 1245604 1246054 1246180 1343405 1343556 1344028 1344292 1344459 1345527 1346103 1346649 1440443 1441169 1442254 1442805 645372
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0656-2015
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