Recall Z-1162-2018 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Arrow International Inc
Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.
| Date | Mar 5, 2018 (initiated Nov 14, 2017) |
| Status | Terminated |
| Reason | Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions. |
| Root cause | Labeling mix-ups |
| Action | On November 16, 2017, an Urgent Medical Device Notification titled "ARROW PSI and Pressure Injectable Multi-Lumen CVC Kits" was issued to customers informing them of the issue, and urging all to take the following actions: 1. Place a copy of this notification and the enclosed Central Line Insertion Checklist with each unit of affected product currently in your inventory. 2. Complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to recalls@teleflex.com. If you have any other questions, feel free to contact your local sales representative or Cus |
| Quantity | 18,124 total |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071538 | ARROW, ARROWG+ARD AND ARROWG+ARD BLUE PLUS PRESSURE INJECTABLE CENTRAL VENOUS CATHETER Arrow International, Inc., Aug 30, 2007 |