PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080360. 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:
614661 716054 817474 913490 913546 913557 913558 913564 913652 914124 915684 915912 915913 1013456 1013457 1014295 1014657 1014658 1015047 1015048 1015158 1015160 1015781 1015782 1016402 1016403 1016404 1016557 1016558 1016559 1016561 1016828 1016829 1113336 1113337 1113338 1113615 1113616 1113698 1113699 1114268 1114269 1115399 1115401 1115402 1115964 1115965 1115966 1116116 1116117 1116118 1117009 1117010 1213733 1213734 1214732 1214733 1216815 1216816 1216817 1216818 1217032 1313934 1314205 1314921 1314922 1314923 1315783 1315784 1316806 1316807 1410093 1410094 1410095 1410417 1410418 1410599 1410600 1410601 1412348
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, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080360. 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:

614661 716054 817474 913490 913546 913557 913558 913564 913652 914124 915684 915912 915913 1013456 1013457 1014295 1014657 1014658 1015047 1015048 1015158 1015160 1015781 1015782 1016402 1016403 1016404 1016557 1016558 1016559 1016561 1016828 1016829 1113336 1113337 1113338 1113615 1113616 1113698 1113699 1114268 1114269 1115399 1115401 1115402 1115964 1115965 1115966 1116116 1116117 1116118 1117009 1117010 1213733 1213734 1214732 1214733 1216815 1216816 1216817 1216818 1217032 1313934 1314205 1314921 1314922 1314923 1315783 1315784 1316806 1316807 1410093 1410094 1410095 1410417 1410418 1410599 1410600 1410601 1412348

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0694-2015

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PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080123 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.

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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

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