RecallRadar

FDA Device recall Z-1166-2018

ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit

On 2018-03-28 the FDA classified a Class II recall of ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit by Arrow International, citing products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of b….

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1166-2018
ClassificationClass II
Statusterminated
Initiated2017-11-14
Published2018-03-28
Last updated2026-09-13 11:54 UTC
CompanyArrow International
DistributionUS

Product

ARROWg+ard Blue PLUS Pressure Injectable Multi-Lumen CVC Kit. Intended to permit venous access to the central circulation.

Reason

Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.

Identifiers

code_infoCDC-42703-P1A CDC-45703-P1A 13F16H0215 13F16H0216 13F16J0157 13F16J0053 13F16J0182 13F16J0186 13F16K0119 13F16K0266

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-1166-2018%22

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