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Recall Observatory FDA recall evidence

Device product

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

Z-1166-2018

November 14, 2017

Class II

Product summary

Firm
Arrow International Inc
Event
Event 79342
Status
Terminated
Classification
Class II
Quantity
18,124 total
Official record key
device-enforcement:Z-1166-2018

Official wording

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.

Code information: CDC-42703-P1A CDC-45703-P1A 13F16H0215 13F16H0216 13F16J0157 13F16J0053 13F16J0182 13F16J0186 13F16K0119 13F16K0266

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.