Recall Z-2489-2015 ยท OBJ Catheter, Ultrasound, Intravascular
Arrow International Inc
Arrow International, Inc. PICC Kits and VPS Access Kits with Touhy Borst Component Catheter, Intravascular, Therapeutic, Ultrasound, Long Term Greater than 30 Days
| Date | Aug 31, 2015 (initiated Jul 30, 2015) |
| Status | Terminated |
| Reason | saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported. |
| Root cause | Under Investigation by firm |
| Action | Arrow International sent an Urgent Medical Device Recall Notification letter dated July 30, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to do the following: If you have affected stock, immediately discontinue use and quarantine any products with the catalog and lot number listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email it to recalls@teleflex.com. This will allow us to document the amount of |
| Quantity | 92902 |
| Distribution | Worldwide Distribution - US nationwide and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073451 | PRESSURE INJECTABLE PICC Arrow International, Inc., Jan 15, 2008 |
| K103255 | VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET Vasonova, Inc., Feb 18, 2011 |
| K121941 | ARROW PICC POWERED BY ARROW VPS STYLET Arrow International (Subsidiary of Teleflex Inc.), Sep 7, 2012 |
| K130876 | CG+ ARROW PICC POWERED BY ARROW VPS STYLET Arrow International, Inc., Apr 26, 2013 |