PKG, BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080291. 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: 42337 43487 844401 844761 845042 848259 940167 941850 942654 942773 945445 945980 1040392 1041058 1042090 1042644 1042646 1140811 1141158 1142154 1142667 1143974 1144313 1144620 1145338 1145890 1145973 1242131 1243368 1244190 1244965 1341566 1342767 1342768 1343714 1345270 1345728 1346217 1440423 1440471
- 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, BIOPSY FORCEPS, SPOON W/PIN, P/N 0250080291. 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:
42337 43487 844401 844761 845042 848259 940167 941850 942654 942773 945445 945980 1040392 1041058 1042090 1042644 1042646 1140811 1141158 1142154 1142667 1143974 1144313 1144620 1145338 1145890 1145973 1242131 1243368 1244190 1244965 1341566 1342767 1342768 1343714 1345270 1345728 1346217 1440423 1440471
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0668-2015
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