Turbo Elite 0.9mm Turbo Elite (TE) RX, Model #410-154, tip diameter 0.9mm/.038 in, 4 Fr, sterile EO. Manufactured by Spe
FDA device recall Z-0976-2009 · posted 2009-02-11 · Terminated
Recall details
- Recalling firm
- Spectranetics Corporation
- Reason for recall
- The catheter pouch label was incorrectly labeled with the wrong size.
- Action taken
- The mislabeled catheter was returned to Spectranetics. The second possible mislabeled catheter was visually inspected by a Spectranetics representative and confirmed the catheter was labeled correctly.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MJQ
- Quantity affected
- 2 units
- Distribution
- Nationwide Distribution including states of TX and FL.
- Date initiated
- 2008-07-04
- Date posted
- 2009-02-11
- Date terminated
- 2009-02-13
- Location
- Colorado Springs, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLIRPATH TURBO EXCIMER LASER CATHETER (RX) -0.9MM, (RX) -1.4MM, (RX) -1.7MM, (RX) -2.0MM, MODEL 310-154, 314-159, 317-15 (K071227) | Spectranetics Corp. | 2007-07-11 |