PKG, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080230. 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: 40727 41812 42276 42321 43396 140312 143267 245172 246071 246923 247037 340652 340653 440289 441514 441892 443352 443353 444984 444985 51299 0543138D 0543898D 0640771D 0641429D 0644144D 0646013D 0647316D 0647549D 0740185D 0744066D 0744695D 0746332D 0840071D 0840907D 0842105D 0843936D 0844813D 0846982D 0846986D 0847650D 0847661D 0847671D 92509 0941061D 0941604D 0941726D 0944836D 0945121D 0945472D 0945725D 0945884D 0945983D 1040247D 1040397D 1040426D 1040985D 1042094D 1042466D 1042503D 1042504D 1042940D 1042942D 1044541D 1045186D 1045983D 1046856D 1140701D 1141744D 1142005D 1143438D 1143439D 1144077D 1144676D 1144677D 1145548D 1145549D 1146121D 1240550D 1242235D 1243162 1243162D 1243163 1243596 1340609 1340610 1340610D 1341875 1341876 1342868 1342868D 1342869 1345090 1345090D 1345799 1440293 181299 511298 521298
- 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, ROTATING HANDLE, W/RATCHET, INSULATED SHAFT, P/N 0250080230. 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:
40727 41812 42276 42321 43396 140312 143267 245172 246071 246923 247037 340652 340653 440289 441514 441892 443352 443353 444984 444985 51299 0543138D 0543898D 0640771D 0641429D 0644144D 0646013D 0647316D 0647549D 0740185D 0744066D 0744695D 0746332D 0840071D 0840907D 0842105D 0843936D 0844813D 0846982D 0846986D 0847650D 0847661D 0847671D 92509 0941061D 0941604D 0941726D 0944836D 0945121D 0945472D 0945725D 0945884D 0945983D 1040247D 1040397D 1040426D 1040985D 1042094D 1042466D 1042503D 1042504D 1042940D 1042942D 1044541D 1045186D 1045983D 1046856D 1140701D 1141744D 1142005D 1143438D 1143439D 1144077D 1144676D 1144677D 1145548D 1145549D 1146121D 1240550D 1242235D 1243162 1243162D 1243163 1243596 1340609 1340610 1340610D 1341875 1341876 1342868 1342868D 1342869 1345090 1345090D 1345799 1440293 181299 511298 521298
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0621-2015
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