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Recall Observatory FDA recall evidence

Device product

Pressure Injectable Multi- Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features and Maximal Barrier Precautions. Permits venous access and catheter introduction to the central circulation.

Z-1159-2018

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-1159-2018

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: ASK-15703-PWBH 13F16K0166

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.