Recall Z-2170-2017 ยท OBJ Catheter, Ultrasound, Intravascular
Arrow International Inc
Arrow(R) VPS(R) Access Kit for use with 4 and 5 Fr. Peripherally Inserted Central Venous Catheters
| Date | Apr 28, 2017 |
| Status | Terminated |
| Reason | Arrow International is notifying each customer who received the affected that product that the kits do not contain important information regarding the 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing. |
| Root cause | Unknown/Undetermined by firm |
| Action | Arrow International sent an Urgent Medical Device Notification letter dated May 2, 2017, to all affected customers to inform them of the issue. The letter will instruct the distributor to notify their customers if the product was further distributed and to return a completed acknowledgement form indicating the amount of units on hand. For further questions, please call (610) 378-0131. |
| Quantity | 3,918 units |
| Distribution | US Distribution to the state of : NC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103255 | VASCULAR POSITIONING SYSTEM TM (VPS TM SYSTEM) STYLET Vasonova, Inc., Feb 18, 2011 |