BEUDAMED
    FDA Recall Open, Classified

    Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular

    Recall: Z-2590-2023 · Initiated August 10, 2023

    Recall

    Recall Number
    Z-2590-2023
    Event Number
    92850
    Firm
    ARROW INTERNATIONAL Inc.
    FEI Number
    3013162291
    Product Code
    LJS
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 10, 2023
    Posted
    September 15, 2023
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

    Description

    Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular

    Reason

    This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

    Action

    Teleflex/Arrow International issue an URGENT MEDICAL DEVICE RECALL notice on 08/10/2023 by FedEx 2nd day mail. The letter explained the problem, risk to patient, and requested the following actions: Medical facilities: Immediately cease use and distribution of affected product and quarantine for return. Distributors: Immediately cease use and distribution of affected product and quarantine for return. Provide a copy of this recall notice to all customers who have received impacted product. Request they complete the Acknowledgement Form and return it to you. Firm is requesting return of the affected product.

    Distribution

    US Nationwide distribution.

    Quantity

    190 units