FDAFDA · Food and drugs·Recall number Z-0710-2015
PKG, 5MM INSERT, ATRAUMATIC GRASPER FORCEPS, DOUBLE ACTION 45CM, P/N 0250080585 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
- 343383 941246 941725 942278 942852 943499 944696 945720 1041625 1042488 1042730 1042738 1042827 1140149 1141793 1142618 1143650 1144500 1145003 1145229 1146369 1146656 1242931 1243555 1244994 1245515 1245818 1340539 1341533 1341554 1342765 1343189 1343300 1343410 1343707 1345828 1346105 1346547 1346654 1440433 1442515 1443224 1443605
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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