ARROW IPN919534Recalls & reported problems

Teleflex Incorporated · Pressure Injectable Arrowg+ard Blue Advance(R) One-Lumen JACC · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

8 other recalls cover devices cleared under the same FDA submission (K132133); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

Apr 21, 2026Open, Classified
Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.
Z-2379-2026 · Root cause: Nonconforming Material/Component · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132133. One submission often covers many models, so check the product and lot details in each record.

Z-1816-2019 · Apr 23, 2019 · Terminated
Arrowg+ard Blue Advance JACC Product Code: JRT 43541 HPHNM
Z-1812-2019 · Apr 23, 2019 · Terminated
Arrow JACC with Chlorag+ard Technology Product Code: JR 42041 HPHNM
Z-1817-2019 · Apr 23, 2019 · Terminated
Arrowg+ard Blue Advance JACC Product Code: JRT 43552 HPHNM
Z-1806-2019 · Apr 23, 2019 · Terminated
Arrowg+ard Blue Advance PICC pre loaded with Arrow VPS" Precision Stylet Product Code: CDC 44052 VPS2
Z-1814-2019 · Apr 23, 2019 · Terminated
Arrow JACC with Chlorag+ard Technology Product Code: JR 42541 HPHNM
Z-1815-2019 · Apr 23, 2019 · Terminated
Arrow JACC with Chlorag+ard Technology Product Code:JR 42563 HPHNM
Z-2015-2018 · Apr 11, 2018 · Terminated
ARROW JACC with Chlorag+ard Technology; Product Code: JR-42063-HPHNM and JR-42563-HPHNM
Z-0207-2016 · Oct 16, 2015 · Terminated
ARROW PICC Kit featuring Chlorag+ard Technology Midline Catheterization Kit ARROW Advantage5 Pressure Injectable PICC Kit Arrow Pressure Injectable Arrow PICC powered by Arrow VPS

Device details

UDI-DI	`10801902188288`
Brand	ARROW
Model	IPN919534
Catalog no.	CDC-42041-JX1A
Company	Teleflex Incorporated
Product code	LJS · Catheter, intravascular, therapeutic, long-term greater than 30 days
Class	Class 2
FDA submission	K132133
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Jan 10, 2024

Device type (GMDN): Central venous catheterization kit, short-term

A collection of devices and materials intended for the short-term (<= 30 days) introduction of a central venous catheter (CVC) for various infusion/aspiration procedures (i.e., non-dedicated). Often referred to as tray, it includes a nonimplantable central venous catheter with devices dedicated to catheter introduction/function (e.g., introducer, guidewire), and non-dedicated supportive devices (e.g., drape, dressings, scalpel). This is a single-use device.

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All Catheter, intravascular, therapeutic, long-term greater than 30 days devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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