Recall Z-1494-2014 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Arrow International Inc
Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter.
| Date | Apr 24, 2014 (initiated Mar 24, 2014) |
| Status | Terminated |
| Reason | Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contain a 50cm catheter. |
| Root cause | Labeling mix-ups |
| Action | A recall notification letter, dated March 24, 2014 was sent to end users. " Urgent Medical Device Recall Notification " |
| Quantity | 789 |
| Distribution | Nationwide Distribution- Including the states of Az, Tn, Fl, Ga, Ca |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121941 | ARROW PICC POWERED BY ARROW VPS STYLET Arrow International (Subsidiary of Teleflex Inc.), Sep 7, 2012 |