Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex-free A Port. 10 Fr. Introducer
FDA device recall Z-0284-2007 · posted 2006-12-19 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Catheter has separated from the infusion port body.
- Action taken
- The recall notification was sent out to their US customers on 9/29/2006.
- Root cause
- Other
- Status
- Terminated
- Product code
- LJT
- Quantity affected
- 890
- Distribution
- Nationwide. The firm is NOT recalling from international accounts.
- Date initiated
- 2006-09-29
- Date posted
- 2006-12-19
- Date terminated
- 2007-06-04
- Location
- Reading, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| A-PORT IMPLANT VASCULAR ACCESS SYST CATH - 75CM (K921475) | Therex Corp. | 1992-10-16 |
| A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM (K875214) | Therex Corp. | 1988-02-19 |