PKG, 5MM INSERT, PARK FORCEPS, P/N 0250080733 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: 541778 645498 746494 940777 940819 942547 943493 1040240 1040242 1041188 1041617 1042440 1042802 1042810 1042824 1042825 1141217 1141787 1142297 1144497 1144989 1145355 1145793 1146356 1146666 1240947 1241795 1242136 1245816 1246637 1342739 1344134 1344201 1344205 1344875 1345230 1345275 1345417 1345518 1345735 1440481 1441633 1441835 1442174 246637
- 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 INSERT, PARK FORCEPS, P/N 0250080733 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:
541778 645498 746494 940777 940819 942547 943493 1040240 1040242 1041188 1041617 1042440 1042802 1042810 1042824 1042825 1141217 1141787 1142297 1144497 1144989 1145355 1145793 1146356 1146666 1240947 1241795 1242136 1245816 1246637 1342739 1344134 1344201 1344205 1344875 1345230 1345275 1345417 1345518 1345735 1440481 1441633 1441835 1442174 246637
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0738-2015
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