eye-pak 7407 Tray Support Cover REF 8065740745

FDA device recall Z-2694-2014 · posted 2014-09-24 · Terminated

Recall details

Recalling firm

Alcon Research, Ltd.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

HMT

Quantity affected

2462

Distribution

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

Date initiated

2014-06-03

Date posted

2014-09-24

Date terminated

2015-07-27

Location

Fort Worth, TX