Stryker Endoscopy Recall: PKG, 5MM X 33CM, INSERT, FENESTRATED GRASPER, P/N 0250080755 Lap
Stryker Endoscopy Recall: PKG, 5MM X 33CM, INSERT, FENESTRATED GRASPER, P/N 0250080755 Lap is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Stryker Endoscopy; Product: PKG, 5MM X 33CM, INSERT, FENESTRATED GRASPER, P/N 0250080755 Laparoscopic Manual Instruments are intended for cutting,
| Recalling firm | Stryker Endoscopy |
|---|---|
| Product | PKG, 5MM X 33CM, INSERT, FENESTRATED GRASPER, P/N 0250080755 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. |
| 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 II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | 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, |
| Recall initiated | 20141117 |
| Recall number | Z-0748-2015 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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