Z-2383-2018Class II

VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO

Name: Z-2383-2018 VPS Rhythm ECG Accessory Pack, REF RHY-100-ECGO
Creator: Arrow International Inc
Published: 2018-05-17
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2018-05-17 / Terminated / root cause: labeling and UDI

FDA source

Arrow International Inc began a recall of 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... on 2018-05-17. FDA classified it as Class II and gives the reason as "Product pouch label may not easily identify the lot number, expiration date and associated symbols". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2383-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-17
Posted: 2018-07-08
Terminated: 2020-12-02
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
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).
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: Product pouch label may not easily identify the lot number, expiration date and associated symbols..
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: On May 17, 2018, Arrow International issued Urgent Medical Device Recall Notices and Response Forms to impacted customers via FedEx 2-day. Customers were advised to take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product codes and lot numbers listed, so that the affected products can be returned to Arrow. 2.To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. Soon after, a customer service representative will contact customers with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Arrow International. 3.If you have no affected stock, please complete the Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to [email protected]. This will allow the firm to document your receipt of the letter. Customers with questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in commerce: 2070 units in total
Distribution: 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
Product codes and lots: Lot Number: 13F17A0288

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2383-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2382-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-07
Z-2383-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-07
Z-2384-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-07
Z-2385-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-18	2018-07-07

Product code LJS

K160925Class IIVPS Rhythm Device with TipTracker TechnologyArrow International, Inc. (A Subsidiary of Teleflex, Inc.) / cleared 2016-12-22

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)