Z-0004-2024Class I

Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS...

Name: Z-0004-2024 Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS...
Creator: ARROW INTERNATIONAL Inc.
Published: 2023-08-10
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2023-08-10 / Open, Classified

FDA source

ARROW INTERNATIONAL Inc. began a recall of Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter... on 2023-08-10. FDA classified it as Class I and gives the reason as "This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0004-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-08-10
Posted: 2023-10-05
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
Product code: LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Reason for recall: This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
FDA root cause: Under Investigation by firm
Action: Teleflex/Arrow International issue an URGENT MEDICAL DEVICE RECALL notice on 08/10/2023 by FedEx 2nd day mail. The letter explained the problem, risk to patient, and requested the following actions: Medical facilities: Immediately cease use and distribution of affected product and quarantine for return. Distributors: Immediately cease use and distribution of affected product and quarantine for return. Provide a copy of this recall notice to all customers who have received impacted product. Request they complete the Acknowledgement Form and return it to you. Firm is requesting return of the affected product.
Quantity in commerce: 172 units
Distribution: US
Product codes and lots: Batch/Lot number 13F22G0508

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0004-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0001-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-04
Z-0002-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-04
Z-0003-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-04
Z-0004-2024	Class I	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-04

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)