Recall Z-1947-2014 ยท LRO General Surgery Tray
Alcon Research, Ltd.
Alcon CUSTOM-PAK containing Anterior Chamber Cannula 27G Component Part Number 585006 contained in Alcon Assembly Numbers 9795-37, 11233-14, and 13334-04. The product is typically inserted through an incision during cataract surgery to deliver balanced salt solution to help anterior chamber space and replace fluids that are lost during surgery.
| Date | Jun 30, 2014 (initiated May 16, 2014) |
| Status | Terminated |
| Reason | Alcon CUSTOM-PAK which is supposed to contain a 27G Anterior Chamber Cannula (27G x 7/8 in) actually contains a 27G Sharp Tip Needle |
| Root cause | Employee error |
| Action | Alcon sent an Urgert Market Withdrawal letter dated May 14, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review their inventory to determine if they have any affected product, place the affected product into quarantine to ensure it is not used, return the attached Response Form via fax to 817-302-4337 or email market.action@Alcon.com. Customers with questions were instructed to call 1-800-862-5266. |
| Quantity | 684 total (525 units in US) |
| Distribution | Nationwide Distribution including North Carolina and Maine |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K880961 | ALCON SURGICAL PROCEDURE PACKS Alcon Laboratories, Apr 29, 1988 |