Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.
This recall has been terminated (originally issued June 19, 2015).
- Company
- Hill-Rom, Inc.
- Recall Initiated
- March 2, 2015
- Posted
- June 19, 2015
- Terminated
- May 13, 2016
- Recall Number
- Z-1820-2015
- Quantity
- 66691 units
- Firm Location
- Batesville, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece.
Distribution
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.
Lot / Code Info
Product #s: 157400; 257400; 157500; 257500
Root Cause
Use error
Action Taken
Customers were notified via telephone and e-mail by 03/02/2015. The firm is requiring customers to complete a submitted response form and certificate of destruction for recalled devices by 03/31/2015. If recalled devices were further distributed the firm is asking customers to conduct a sub recall and forward notice of the recall. Public contact is Aspen Medical Europe Ltd, QA Department, Lynda McConaghy-QARA Manager, Lynda.McConaghy@aspenmedicaleurope.com , or +44 (0)1527 587716.