FDA-Device2015-07-01Class II

Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.

Hill-Rom, Inc.
Hazard

The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece.

Sold states
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.
Affected count
66691 units
Manufactured in
1069 State Road 46 E, Batesville, IN, United States
Products
Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1820-2015

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