Recall Z-1228-2017 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Arrow International Inc
Vascular catheter introduction kit The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media.
| Date | Jan 11, 2017 |
| Status | Terminated |
| Reason | There have been complaints for peel away sheaths flaring |
| Root cause | Device Design |
| Action | Arrow International mailed an Urgent Medical Device Advisory Notification letter to affected customers on 01/13/2017 to inform them of the issue. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990. |
| Quantity | 215,703 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K930129 | ARROW PICC-PERIPHERALLY INSERTED CENTRAL CATHETER Arrow Intl., Inc., Mar 28, 1994 |