FDAFDA · Food and drugs·Recall number Z-0663-2015
PKG, TROCAR, 11MM, PYRAMIDAL TIP, P/N 0250080156. 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.
Published December 24, 2014 · Recall initiated: November 17, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Endoscopy
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to Algeria, Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Ecuador, France, Germany, Greece, Guam, Guatemala, India, Italy, Japan, Jordan, Kuwait, Latin America, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.
- Lot
- 197 38410 38539 39800 43905 44707 45337 45663 46563 47266 47477 47499 47500 47957 48256 48346 48694 49042 49141 50045 51396 51915 53499 54427 57166 57384 57979 58704 59130 59453 60572 61045 62137 63233 64030 64480 66874 67351 67645 67981 69931 73431 75611 75612 76147 76197 76198 79810 80433 83797 84016 84191 85143 85382
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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