FDA-Device2018-07-18Class II
VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ 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 trad
Arrow International Inc
Hazard
Product pouch label may not easily identify the lot number, expiration date and associated symbols..
Sold states
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
Affected count
2070 units in total
Manufactured in
2400 Bernville Rd, Reading, PA, United States
Products
VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ 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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2382-2018Don't want to check this manually?
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