Arrow International Inc recalls VPS Rhythm ECG Accessory Pack with Johans Adapter, REF RHY-100-ECGJ Product Usage: To provide real time tip location in…

Recall date

May 17, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2382-2018

FDA classification

Class II

Brand / firm

Arrow International Inc

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).