PKG, SPRING HANDLE, P/N 0250080237. 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 - Dangerous

🏥 Medical Devices Recalled: November 17, 2014 Stryker Endoscopy Surgical Instruments Nationwide

What Should You Do?

Check if you have this product:
413144 414465 614433 716055 717057 717566 913220 913565 913566 913625 913763 914558 914559 914560 914654 914655 915026 915062 915269 915270 915430 915791 915895 1013200 1013201 1013277 1013393 1014635 1015163 1015164 1015774 1015863 1016125 1016405 1016407 1016555 1016556 1113333 1113334 1113335 1113340 1114205 1114544 1114545 1114546 1115529 1115530 1115650 1115652 1115653 1116111 1116113 1116460 1116461 1117176 1117177 1213128 1213258 1213259 1213973 1213975 1214001 1214735 1214736 1215298 1215299 1216023 1216024 1216228 1216229 1216288 1216721 1216722 1313330 1313331 1313332 1313805 1313806 1313947 1313948 1313972 1314203 1314204 1314472 1315785 1315786 1315787 1410413
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, SPRING HANDLE, P/N 0250080237. 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:

413144 414465 614433 716055 717057 717566 913220 913565 913566 913625 913763 914558 914559 914560 914654 914655 915026 915062 915269 915270 915430 915791 915895 1013200 1013201 1013277 1013393 1014635 1015163 1015164 1015774 1015863 1016125 1016405 1016407 1016555 1016556 1113333 1113334 1113335 1113340 1114205 1114544 1114545 1114546 1115529 1115530 1115650 1115652 1115653 1116111 1116113 1116460 1116461 1117176 1117177 1213128 1213258 1213259 1213973 1213975 1214001 1214735 1214736 1215298 1215299 1216023 1216024 1216228 1216229 1216288 1216721 1216722 1313330 1313331 1313332 1313805 1313806 1313947 1313948 1313972 1314203 1314204 1314472 1315785 1315786 1315787 1410413

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0627-2015

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