Steriseal-Cannula Ophthalmic; Bi-Manual Irrigating/Aspirating Handpiece.
FDA device recall Z-1820-2015 · posted 2015-06-19 · Terminated
Recall details
- Recalling firm
- Hill-Rom, Inc.
- Reason for recall
- The metal cannula attached to the handpiece can rotate and become dislodged from the plastic handpiece.
- 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.
- Root cause
- Use error
- Status
- Terminated
- Product code
- HMX
- Quantity affected
- 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.
- Date initiated
- 2015-03-02
- Date posted
- 2015-06-19
- Date terminated
- 2016-05-13
- Location
- Batesville, IN
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