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Terminated

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

FDA Recall Z-1820-2015 · Posted 2015-06-19

Recalling FirmHill-Rom, Inc.
Recall StatusTerminated
Product CodeHMX
Date Initiated2015-03-02
Date Terminated2016-05-13
Product Quantity66691 units

Reason for Recall

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

Firm 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, [email protected] , or +44 (0)1527 587716.

Root Cause

Use error

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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