Recall Z-2694-2014 ยท HMT Drape, Patient, Ophthalmic
Alcon Research, Ltd.
eye-pak 7407 Tray Support Cover REF 8065740745
| Date | Sep 24, 2014 (initiated Jun 3, 2014) |
| Status | Terminated |
| Reason | The peel pouches of the Tray Support Covers may be insufficiently sealed so that sterility cannot be assured. |
| Root cause | Packaging process control |
| 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 wil |
| Quantity | 2462 |
| Distribution | Worldwide Distribution - Nationwide Distribution and the countries of Australia, Belgium, and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.