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Recall Observatory FDA recall evidence

Device product

Arrow¿ Pressure Injectable Two-Lumen PICC Kit, Product Number: EU-05052-HPMSB

Z-1325-2018

December 22, 2017

Class II

Product summary

Firm
Arrow International Inc
Event
Event 79512
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-1325-2018

Official wording

Reason: Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

Code information: Lot Number: 13F17B0123

Distribution pattern: Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.