RecallRadar

FDA Device recall Z-1152-2018

ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS¿ catheter permits venous access to cent…

On 2018-03-28 the FDA classified a Class II recall of ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS¿ catheter permits venous access to cent… by Arrow International, citing certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and Unique Device Identification (UDI) information.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1152-2018
ClassificationClass II
Statusterminated
Initiated2017-12-21
Published2018-03-28
Last updated2026-09-13 11:54 UTC
CompanyArrow International
DistributionFL

Product

ARROWg+ard Blue PLUS catheter, Catalog Number: ASK-45854-NG Product Usage: The ARROWg+ard Blue PLUS¿ catheter permits venous access to central circulation by way of subclavian, jugular, and femoral veins. The ARROWg+ard technology is intended to provide protection against catheter-related bloodstream infections (CRBSIs). It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use (> 30 days). Clinical effectiveness of the ARROWg+ard Blue PLUS¿ catheter in preventing CRBSIs compared to the original ARROWg+ard Blue¿ catheter has not been studied.

Reason

Certain lots may be missing information at the bottom of the lid including the lot number, expiration date, and Unique Device Identification (UDI) information.

Identifiers

code_infoLot Numbers: 23F16H0744, 23F16J0072, 23F17B0781

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1152-2018%22

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