Recall Z-1820-2015 ยท HMX Cannula, Ophthalmic
Hill-Rom, Inc.
Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.
| Date | Jun 19, 2015 (initiated Mar 2, 2015) |
| Status | Terminated |
| Reason | The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece. |
| Root cause | Use error |
| Action | 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. |
| Quantity | 66691 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.