Recall Z-2383-2018 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Arrow International Inc
VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO 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 lowe
| Date | May 17, 2018 |
| Status | Terminated |
| Reason | Product pouch label may not easily identify the lot number, expiration date and associated symbols.. |
| Root cause | Labeling False and Misleading |
| Action | 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 recalls@teleflex.com. Soon after, a customer service representative will conta |
| Quantity | 2070 units in total |
| Distribution | US Nationwide Distribution in the states of AR, AZ, CT, FL, GA, IL, IN, KS, KY, MA, MI, MN, MO, NC, NJ, NY, OH, PA, SC, TX, VA & WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160925 | VPS Rhythm Device with TipTracker Technology Arrow International, Inc. (A Subsidiary of Teleflex, Inc.), Dec 22, 2016 |