Recall Z-1740-2015 ยท KAM Cannula, Sinus
Acclarent, Inc.
RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. .
| Date | Jun 9, 2015 (initiated Apr 28, 2015) |
| Status | Terminated |
| Reason | Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date. |
| Root cause | Nonconforming Material/Component |
| Action | Acclarent sent an Urgent Medical Device Recall letter dated May 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed that if the affected catheter is still in inventory, it should be isolated and returned to Acclarent per instructions. Questions should be addressed to Gabriel Alfageme, Field Action Coordinator at 1-650-687-5398. |
| Quantity | 986 |
| Distribution | US in the state of Texas |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.