Arrow International Inc: Medical Device Recall in 2018 - (Recall #: Z-2382-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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).

Product Classification:

Class II

Date Initiated: May 17, 2018

Date Posted: July 18, 2018

Recall Number: Z-2382-2018

Event ID: 80299

Reason for Recall:

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

Status: Terminated

Product Quantity: 2070 units in total

Code Information:

Lot Numbers: 13F17A0287 & 13F17C0018

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

Voluntary or Mandated:

Voluntary: Firm initiated