Recall Z-1702-2015 ยท LRO General Surgery Tray
Alcon Research, Ltd.
The Alcon Custom Pak. The Alcon Customer Pak is an assemblage of single-use medical devices and accessories designed by medical professionals for specific ophthalmic surgical procedures. Some Paks contain the Devon Light Glove.
| Date | Jun 9, 2015 (initiated Apr 28, 2015) |
| Status | Terminated |
| Reason | The supplier of the Devon Light Glove, a component of the Alcon Custom PAK, recalled the gloves due to the potential for splits and holes on the glove. Should the user be unaware that the Light Glove is torn/split, surgical site infections are possible. |
| Root cause | Nonconforming Material/Component |
| Action | Alcon sent a Recall letter dated April 28, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter included a return form and instructions for credit. Customers were instructed to review inventory for any affected units, segregat the product to ensure it is not used, and return the attached Response Form via fax or email to Alcon. For questions or need assistance with obtaining replacement products contact Alson Customer service at 800-862-5266. |
| Quantity | 219,680 units |
| Distribution | Worldwide Distribution - US Nationwide and the countries of Australia and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K880961 | ALCON SURGICAL PROCEDURE PACKS Alcon Laboratories, Apr 29, 1988 |