PKG, BIPOLAR FORCEPS, FENESTRATED, 33CM, P/N 0250080120 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:
Serial/Lot 06CON06110 06CON06111 0816588/0816395 0816693/0816395 0913442/0817444 0913984/1014813 0914894/1013609 0914894/1014814 0914894/1016062 0914894/1016825 0915431/1016825 1015779/0914894 1016736/1114541 1016739/1016398 1016739/1113020 1016739/1114541 1016846/1114541 1113331/1115651 1113332/1115651 1114831/1115651 1115971/1213123 1116462/1213123 1116463/1213978 1116463/1213979 1314474/1314476
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 0250080120 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:

Serial/Lot 06CON06110 06CON06111 0816588/0816395 0816693/0816395 0913442/0817444 0913984/1014813 0914894/1013609 0914894/1014814 0914894/1016062 0914894/1016825 0915431/1016825 1015779/0914894 1016736/1114541 1016739/1016398 1016739/1113020 1016739/1114541 1016846/1114541 1113331/1115651 1113332/1115651 1114831/1115651 1115971/1213123 1116462/1213123 1116463/1213978 1116463/1213979 1314474/1314476

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0593-2015

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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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Class I - Dangerous

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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