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Recall Observatory FDA recall evidence

Device product

Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.

Z-2338-2017

May 09, 2017

Class II

Product summary

Firm
Arrow International Inc
Event
Event 77232
Status
Terminated
Classification
Class II
Quantity
27,485 units distributed in U.S., 4,371 units distributed internationally
Official record key
device-enforcement:Z-2338-2017

Official wording

Reason: The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.

Code information: Material number: EU-04041-HPMSB, EU-05052-HPMSB, EU-05041-HPMSB Device Listing D000801

Distribution pattern: Worldwide Distribution - US (nationwide) and Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.