Runthrough NS Tapered PTCA Guidewire, item code number TW*DP418FH Product Usage The Runthrough NS guidewire is used to f
FDA device recall Z-2858-2011 · posted 2011-07-20 · Terminated
Recall details
- Recalling firm
- Terumo Medical Corporation
- Reason for recall
- Baloon catheter guidewires may become uncoiled during angioplasty procedures.
- Action taken
- Terumo Medical Corporation initiated contacting consignees on June 3, 2011 via an in-person visit to hand deliver an "URGENT PRODUCT BULLETIN: TERUMO PRODUCT SAFETY ALERT" letter dated June 3, 2011. The letter emphasized to consignees the importance of following the current instructions and recommendations provided to minimize the potential for damage during use and removal of the recalled product. For further questions, please contact your Terumo Territory Manager or call (800) 283-7866 and ask to speak with the Runthrough NS Guidewire Product Manager, at extension 4129.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 70 units
- Distribution
- Nationwide (USA) Distribution -- including the states of: CT, GA, and SC.
- Date initiated
- 2011-06-03
- Date posted
- 2011-07-20
- Date terminated
- 2011-07-27
- Location
- Elkton, MD
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RUNTHROUGH NS (K063695) | Terumo Medical Corp. | 2007-04-27 |