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Terminated

eye-pak 7407 Tray Support Cover REF 8065740745

FDA Recall Z-2694-2014 · Posted 2014-09-24

Recalling FirmAlcon Research, Ltd.
Recall StatusTerminated
Product CodeHMT
Date Initiated2014-06-03
Date Terminated2015-07-27
Product Quantity2462

Reason for Recall

The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured.

Firm Action

Alcon Research sent an Urgent Medical Device Recall letter dated June 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please follow these important steps: 1) Review your inventory of Tray Support Covers to determine if you have any units from the affected Lots in stock. 2) Place the product aside to ensure it is not used. 3) Return the attached Response Form via fax or email to Alcon. Please return the Response Form even if you do not have any inventory from the affected lots. 4) Alcon will contact you to arrange the return of your inventory. If you have any further questions, concerns, or need assistance with obtaining replacement product, please contact Alcon Customer Service at 1-800-862-5266.

Root Cause

Packaging process control

Distribution Pattern

Worldwide Distribution - Nationwide Distribution and the countries of Australia, Belgium, and Canada.

Official Source

View FDA Recall →

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

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