Z-0102-2023Class II

ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF...

Name: Z-0102-2023 ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF...
Creator: ARROW INTERNATIONAL Inc.
Published: 2022-09-14
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2022-09-14 / Terminated / root cause: labeling and UDI

FDA source

ARROW INTERNATIONAL Inc. began a recall of ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the... on 2022-09-14. FDA classified it as Class II and gives the reason as "Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for...". 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-0102-2023
Classification: Class II
Status: Terminated
Initiated: 2022-09-14
Posted: 2022-10-19
Terminated: 2024-01-19
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: ARROW Pressure Injectable Arrowg+ard Blue Advance Two-Lumen Midline Kit, 5.5 Fr, 15 cm, .018 Inch dia., REF ASK-41552-JHVA1. For peripheral access to the venous system for intravenous therapy, blood sampling, infusion, and pressure injection of contrast media.
Product code: PND Midline Catheter
Reason for recall: Mislabeling: the corrugate label, lidstock, banner card, and peel sticker accompanying the affected product incorrectly displays a double lumen 5.5 French catheter (and related priming volumes and kit contents for product code ASK-41552-JHVA1), instead of the packaged single-lumen 4.5 French catheter (and related priming volumes and kit contents for product code ASK-41541-JHVA1).
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: The firm sent an URGENT MEDICAL DEVICE NOTFICATION to its sole consignee on 09/15/2022, by FedEx 2-day mail. The letter explained the reason for recall and requested the following: "Please adhere to the following actions: 1. Check your inventory for products in scope of this advisory notice. 2. If you do not have affected product, mark the applicable checkbox on the Acknowledgement Form (Appendix 2) and return the form to Teleflex Customer Service using the contact information below. 3. If you have affected product, mark the applicable checkbox on the Acknowledgement Form (Appendix 2), return the form to Teleflex Customer Service using the contact information below, and place a copy of this advisory notice with all affected products. Adverse reactions or quality problems experienced with the use of this product should be reported to Teleflex Customer Service using the contact information below or may also be reported to the FDA s MedWatch Adverse Event Reporting program either by phone at 1-888-INFO-FDA (1-888-463-6332) or online at https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverseevent-reporting-program. Transmission of this Advisory Notice This advisory notice should be passed on to all persons who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please consider end users, clinicians, risk managers, supply chain/distribution centres, etc., in the circulation of this notice. Please maintain awareness of this notice until all required actions have been completed in your organization.
Quantity in commerce: 18 devices
Distribution: US Nationwide distribution in the state of Florida.
Product codes and lots: UDI (01)10801902144284(17)230731(11)220504(10)13F22C0757

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0102-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0102-2023	Class II	Terminated	Voluntary: Firm initiated	2022-10-26	2022-10-19

Product code PND

K161313Class IIARROW Pressure Injectable Midline Catheter with Chlorag+ard Antimicrobial and Antithrombogenic TechnologyArrow International, Inc. (Subsidiary of Teleflex, Inc.) / cleared 2016-08-24

MDM coverage of this record lists here, newest first.

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)