PKG, NEEDLE HOLDER, CURVED LEFT, P/N 0250080341. 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: 247810 244921 340067 343901 544103 644138 741292 744238 940159 940784 942133 942134 942279 942685 943256 943444 943446 943740 943859 943860 944295 944829 944925 945726 1040111 1040424 1041099 1041277 1041381 1042093 1042502 1042938 1045028 1045477 1045934 1046110 1046399 1046929 1140657 1141381 1142928 1143002 1143269 1144233 1144241 1144347 1144627 1144657 1145409 1145678 1145965 1145970 1146360 1146655 1147045 1240113 1240952 1241423 1241810 1241811 1241939 1242460 1244168 1244186 1244529 1245023 1245443 1246066 1341576 1341578 1341579 1343713 1344281 1344463 1440469
- 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, NEEDLE HOLDER, CURVED LEFT, P/N 0250080341. 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:
247810 244921 340067 343901 544103 644138 741292 744238 940159 940784 942133 942134 942279 942685 943256 943444 943446 943740 943859 943860 944295 944829 944925 945726 1040111 1040424 1041099 1041277 1041381 1042093 1042502 1042938 1045028 1045477 1045934 1046110 1046399 1046929 1140657 1141381 1142928 1143002 1143269 1144233 1144241 1144347 1144627 1144657 1145409 1145678 1145965 1145970 1146360 1146655 1147045 1240113 1240952 1241423 1241810 1241811 1241939 1242460 1244168 1244186 1244529 1245023 1245443 1246066 1341576 1341578 1341579 1343713 1344281 1344463 1440469
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0690-2015
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