FDAFDA · Food and drugs·Recall number Z-0633-2015
PKG, CLAW FORCEPS, DOUBLE ACTION, P/N 0250080245. 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
- 43240 143822 646341 841071 845057 847851 848110 940791 941351 943551 943748 944835 945745 1040099 1040976 1041991 1042472 1042687 1042702 1042706 1141976 1142463 1143133 1144329 1144624 1145286 1145818 1146347 1146686 1240540 1241942 1241943 1242475 1243542 1243543 1244257 1341592 1341593 1341597 1345522 1346223 1346539 1440407 1440672 1440673 1440892 1440893
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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