Recall Z-2382-2018— Arrow International Inc

Name: FDA recall Z-2382-2018
Creator: U.S. Food and Drug Administration
Published: 2018-05-17

Class II · Terminated

Class II FDA medical device recall by Arrow International Inc, initiated 2018-05-17, terminated 2020-12-02. It names one FDA 510(k) clearance: K160925. Product: 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).. Reason: Product pouch label may not easily identify the lot number, expiration date and associated symbols...

Recalling firm: Arrow International Inc
Classification: Class II
Status: Terminated
Initiated: 2018-05-17
Terminated: 2020-12-02
Firm location: Reading, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K160925 — VPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.)·cleared 2016-12-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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).

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.