FDAFDA · Food and drugs·Recall number Z-0713-2015
PKG, 5MM SHAFT, NEEDLE HOLDER, STRAIGHT, 45CM, P/N 0250080588 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
- 342649 343202 543358 644784 744458 747492 747493 840089 842490 847795 940117 943497 943730 943858 945716 1041182 1042740 1042741 1043533 1045231 1046109 1140858 1141657 1142152 1143125 1241809 1242140 1243099 1244074 1245022 1246067 1340117 1341249 1346653 1440696 1442806
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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