Device product
Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.
Z-1820-2015
Product summary
- Firm
- Hill-Rom, Inc.
- Event
- Event 70675
- Status
- Terminated
- Classification
- Class II
- Quantity
- 66691 units
- Official record key
device-enforcement:Z-1820-2015
Official wording
Reason: The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece.
Code information: Product #s: 157400; 257400; 157500; 257500
Distribution pattern: Worldwide Distribution-US (nationwide) including the states of MI & PA, and the countries of Belgium, England, Italy, Czech Republic, Turkey, Greece, Ireland, Scotland, Spain, and Lebanon.
Derived failure modes
-
Unknown
The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece.