Recall Z-0690-2018 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Arrow International Inc
ARROW PICC powered by ARROW VPS Stylet
| Date | Oct 17, 2017 |
| Status | Terminated |
| Reason | The kit may contain an incorrect catheter component. Kits that should contain a 40cm catheter may contain a 55cm catheter. |
| Root cause | Mixed-up of materials/components |
| Action | On October 17, 2017 an URGENT Medical Device Recall letter titled "ARROW PICC powered by ARROW VPS Stylet" was mailed to customers instructing them to review inventory and quarantine all affected product which will be returned to the firm. Questions or concerns can be directed to Customer Service at 18662466990. |
| Quantity | 601 eaches |
| Distribution | AZ, CA, GA, MA, MO, NY, VA |
| 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 |