Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central
FDA device recall Z-1494-2014 · posted 2014-04-24 · Terminated
Recall details
- Recalling firm
- Arrow International Inc
- Reason for recall
- Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contain a 50cm catheter.
- Action taken
- A recall notification letter, dated March 24, 2014 was sent to end users. " Urgent Medical Device Recall Notification "
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- LJS
- Quantity affected
- 789
- Distribution
- Nationwide Distribution- Including the states of Az, Tn, Fl, Ga, Ca
- Date initiated
- 2014-03-24
- Date posted
- 2014-04-24
- Date terminated
- 2015-09-21
- 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 |
|---|---|---|
| ARROW PICC POWERED BY ARROW VPS STYLET (K121941) | Arrow International (Subsidiary of Teleflex Inc.) | 2012-09-07 |