BEUDAMED
    FDA Recall Open, Classified

    ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FMH1; c) REF ASK-04220-HHC; d) REF ASK-04220-KSP; e) REF ASK-04220-PSU; f) REF ASK-04220-UCL1; g) REF ASK-04500-AH; h) REF ASK-04500-HF-S; i) REF NA-04220-S1A; j) REF NA-04220-X1A; k) REF RA-04220; l) REF RA-04220-W

    Recall: Z-1267-2024 · Initiated February 12, 2024

    Recall

    Recall Number
    Z-1267-2024
    Event Number
    94033
    Firm
    ARROW INTERNATIONAL Inc.
    FEI Number
    3013162291
    Product Code
    DQX
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    February 12, 2024
    Posted
    March 21, 2024
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437

    Description

    ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FMH1; c) REF ASK-04220-HHC; d) REF ASK-04220-KSP; e) REF ASK-04220-PSU; f) REF ASK-04220-UCL1; g) REF ASK-04500-AH; h) REF ASK-04500-HF-S; i) REF NA-04220-S1A; j) REF NA-04220-X1A; k) REF RA-04220; l) REF RA-04220-W

    Reason

    Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to resistance of the guidewire handle/chamber during use. The possible immediate health consequences of the component issue are arterial vasospasm and vessel injury arising from multiple arterial punctures with repeated attempts.

    Action

    Teleflex/ARROW INTERNATIONAL issued an "URGENT MEDICAL DEVICE RECALL" notice to its consignees on 02/12/2024 via letter delivered via FedEx. The notice explained the issue, potential risk, and requested the following actions: Identify affected product in inventory, cease use, and quarantine pending return. If affected product is found, mark the applicable checkbox on the Acknowledgement Form and fax it to 1-855-419-8507, including Attn: Customer Service or using the e-mail address [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. If no product is inventory or on hand, mark the applicable checkbox on the Acknowledgement Form and return the form to Teleflex at the contact details provided. Distributors: Provide this field safety notice to all customers who have received impacted product. Each of your customers is then required to complete the Acknowledgement Form and return it to you. Immediately check your inventory for impacted product. Cease use and distribution of impacted product and immediately quarantine the affected product. You may then return all product in scope. Should you require further information or support concerning this issue, please contact Customer Service via email: [email protected], phone: 1-866-396-2111, or FAX: 1-855-419-8507 using the details provided below. Customer Service hours of operation are 8am 7pm EST.

    Distribution

    Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: AE, AR, AT, AU, BE, BH, BR, CA, CN, CO, CY, DE, EC, EE, ES, FR, GR, HK, HR, IT, KW, LB, LU, MX, MY, NL, NZ, PH, PL, QA, RU, SA, SE, SG, SI, TH, TW, and UK.

    Quantity

    1,160,470 devices