Device product
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 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).
Z-2383-2018
Product summary
- Event
- Event 80299
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2070 units in total
- Official record key
device-enforcement:Z-2383-2018
Official wording
Reason: Product pouch label may not easily identify the lot number, expiration date and associated symbols..
Code information: Lot Number: 13F17A0288
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
Derived failure modes
-
Unknown
Product pouch label may not easily identify the lot number, expiration date and associated symbols..