BEUDAMED
    FDA Recall Terminated

    Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072

    Recall: Z-2058-2019 · Initiated May 29, 2019

    Recall

    Recall Number
    Z-2058-2019
    Event Number
    83026
    Firm
    Zyno Medical LLC
    FEI Number
    3006575795
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 29, 2019
    Terminated
    June 22, 2020
    Address
    177 Pine St, Natick, MA, 01760-1331

    Description

    Zyno Medical Administration Set -105"ADMIN SET 20DP, W/2 Y SITE, CVCLMPS- For Use with Zyno Medical Infusion pumps or Gravity Feed Product Code:B2-70072

    Reason

    Administration sets assembled with inverted pinch clamp cause the fluid from the distal end of the administration set to be pumped to the proximal end of the tubing when secondary set is used with the primary set. Thus, instead of delivering fluid to the patient, blood may be drawn from the patient if there is space in the drug container to hold extra volume of fluid, under the condition that the reversed pinch clamp is not identified

    Action

    On May 29, 2019 Zyno issued letter to the Distributor advising of the problem and health risk and action to take: remove all recalled products with codes, cease use and immediately and return them to Zyno Medical for replacement from unaffected lots. Call or email for instructions on the return of products: (508) 907-7772 (Monday to Friday, 9:30 a.m. to 5 p.m. EST) or [email protected] to acknowledge receiving this recall notice. Zyno issued a follow-up recall letter on 6/10/19 via email to the Distributor to issue to the user/customer level.

    Distribution

    MA

    Quantity

    354 cases (50/case)=17700