Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UH...
FDA Recall #Z-1334-2018 — Class II — December 22, 2017
Product Description
Arrowg+ard Blue(R) PSI Kit, (1) For use with 7 - 7.5 Fr. Catheters Part Number (PN): ASK-29804-UHN2; (2) For use with 7.5 - 8 Fr. Catheters PN: ASK-29903-UCD
Reason for Recall
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Recalling Firm
Arrow International Inc — Reading, PA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Distribution
Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
Code Information
Lot Numbers: (1) 13F17D0188, 13F17E0570; (2) 13F17E0660
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated