BEUDAMED
    FDA Enforcement Class II Terminated

    BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.

    Recall: Z-1969-2020 · Reported May 20, 2020

    Enforcement

    Recall Number
    Z-1969-2020
    Event ID
    85525
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BD SWITZERLAND SARL
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2020
    Initiation Date
    April 9, 2020
    Classification Date
    May 13, 2020
    Termination Date
    November 2, 2020
    Address
    Terre Bonne Park A4, Route De Crassier 17, Eysins, N/A, N/A, Switzerland

    Description

    BD Alaris PCEA Administration Set, Microbore Tubing with Yellow Identification Stripe ASV, Catalog Number 30893-04 (OUS Only) - Product Usage: Microbore Tubing with Yellow Identification Stripe Anti-siphon Valve Use Aseptic Technique Set cannot be used for gravity infusion. 1. Connect PCA syringe to female luer on administration set. 2. Push on syringe plunger to prime set. 3. Refer to PCA module Directions for Use for complete loading and operating instructions. Notes: The set should be changed according to facility protocol or in accordance with currently recognized guidelines for IV therapy. Antisiphon sets cannot be primed by gravity.

    Reason

    The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication.

    Code Info

    Lot Numbers: 19016079 19036183 19045426 19045426 19115483 19115483

    Distribution

    Worldwide distribution - US Nationwide Distribution and the countries of Canada, Belgium.

    Quantity

    110,350