PKG, BABCOCK FORCEPS, P/N 0250080321. 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: 140571 140572 140590 442506 542896 643523 646838 741305 741307 744923 842628 842632 842638 842640 847869 847870 847872 847873 847877 847878 847880 847881 847885 847886 1041276 1042935 1042951 1045190 1046166 1046900 1046901 1140664 1140821 1142174 1142665 1143446 1143728 1144692 1145109 1146164 1146165 1146388 1146900 1146901 1147163 1240407 1240955 1241953 1241954 1242409 1243807 1244132 1244241 1244441 1245480 1246060 1246405 1340290 1341254 1341835 1341836 1343535 1343993 1346493 1440592 1440788 1440789
- 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, BABCOCK FORCEPS, P/N 0250080321. 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:
140571 140572 140590 442506 542896 643523 646838 741305 741307 744923 842628 842632 842638 842640 847869 847870 847872 847873 847877 847878 847880 847881 847885 847886 1041276 1042935 1042951 1045190 1046166 1046900 1046901 1140664 1140821 1142174 1142665 1143446 1143728 1144692 1145109 1146164 1146165 1146388 1146900 1146901 1147163 1240407 1240955 1241953 1241954 1242409 1243807 1244132 1244241 1244441 1245480 1246060 1246405 1340290 1341254 1341835 1341836 1343535 1343993 1346493 1440592 1440788 1440789
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0684-2015
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