RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a m
FDA device recall Z-1740-2015 · posted 2015-06-09 · Terminated
Recall details
- Recalling firm
- Acclarent, Inc.
- Reason for recall
- Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- KAM
- Quantity affected
- 986
- Distribution
- US in the state of Texas
- Date initiated
- 2015-04-28
- Date posted
- 2015-06-09
- Date terminated
- 2015-06-10
- Location
- Menlo Park, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.