Recall Z-0179-2018 ยท OBJ Catheter, Ultrasound, Intravascular
Arrow International Inc
Arrow(R) VPS(R) Access Kit for use with 4 Fr. Peripherally Inserted Central Venous Catheter The intended use of the VPS Stylet and Console (VPS System) is to quickly and accurately guide market available peripherally inserted central catheters (PICCs) to the goal location which is to the cavo-atrial junction near the sino-atrial node
| Date | Jun 1, 2017 |
| Status | Terminated |
| Reason | There is a possibility that the finished good kits may contain 5 Fr peel-away sheaths instead of the required 4 Fr peel-away sheaths. |
| Root cause | Mixed-up of materials/components |
| Action | Arrow International sent an Urgent Medical Device Recall Notification letter dated June 1, 2017, and Recall Acknowledgement Form to their domestic consignees via FedEx 2-day. Customers were advised to immediately inspect stock, discontinue use and quarantine any products with the product codes and lot numbers listed, so that the affected products can be returned to Arrow. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow the firm to document the amount of product you hav |
| Distribution | Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD |
| 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 |