10.5 Fr. Percor STAT-DL intra-Aortic Balloon Catheter Insertion Kits which contain a Datascope 11.5 Fr. 11'' introducer
FDA device recall Z-0916-03 · posted 2003-06-05 · Terminated
Recall details
- Recalling firm
- Datascope Corp
- Reason for recall
- 10.5 Fr. Percor STAT-DL Intra-Aortic Balloon Insertion Kit, Introducer Sheath failed water leak test during final inspection.
- Action taken
- Recall letters were sent via US mail return receipt requested to customers on 3/31/2003. Sales representatives received a letter on 3/28/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- DSP
- Quantity affected
- 60 units
- Distribution
- Product was distributed domestically to hospitals nationwide. There are no US government or foreign consignees.
- Date initiated
- 2003-03-21
- Date posted
- 2003-06-05
- Date terminated
- 2003-08-01
- Location
- Fairfield, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0 (K964987) | Datascope Corp. | 1997-03-17 |