Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW Product Usage: To provide real time tip location information of a central venous catheter by utilization of ECG to observe P-wave changes as the tip approaches the right atrium of the heart via the Superior Vena Cava (SVC). The VPS Rhythm Device is appropriate for final catheter tip placement in any catheter that is intended to be placed in the lower 1/3 of the SVC near the cavo-atrial junction (CAJ). Catheters that are traditionally considered CVCs that are intended to be placed in the right atrium, or any location other than the lower 1/3 SVC (e.g. chronic hemodialysis catheters placed in the right atrium).

Product pouch label may not easily identify the lot number, expiration date and associated symbols..

On May 17, 2018, Arrow International issued Urgent Medical Device Recall Notices and Response Forms to impacted customers via FedEx 2-day. Customers were advised to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed, so that the affected products can be returned to Arrow. 2.To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. Soon after, a customer service representative will contact customers with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International. 3.If you have no affected stock, please complete the Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow the firm to document your receipt of the letter. Customers with questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.