Z-2384-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 18, 2018
- Initiation Date
- May 17, 2018
- Termination Date
- December 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2070 units in total
Product Description
VPS TipTracker Stylet Accessory, REF RHY-177-TTSAP 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).
Reason for Recall
Product pouch label may not easily identify the lot number, expiration date and associated symbols..
Distribution Pattern
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
Code Information
Lot Number: 13F17G0074