BEUDAMED
    FDA Recall Terminated

    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1841541, REF/Catalog No. 60M184154, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801

    Recall: Z-0030-2015 · Initiated August 25, 2014

    Recall

    Recall Number
    Z-0030-2015
    Event Number
    69085
    Firm
    Navilyst Medical, Inc
    FEI Number
    3017892510
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 25, 2014
    Posted
    October 7, 2014
    Terminated
    March 10, 2017
    Address
    10 Glens Falls, Technical Park Glens Falls, NY, 12801

    Description

    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1841541, REF/Catalog No. 60M184154, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801

    Reason

    NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.

    Action

    BD Medical sent an Urgent Voluntary Medical Device Recall letter dated July 22, 2014, to all affected customers via Federal Express on August 25, 2014. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to segregate and quarantine all affected product. Immediately discontinue shipment of the affected product. Complete the Recall Response Card form and fax it back to BD at 1-201-847-6990. If the affected product was further distributed cusotmers should identify their cusotmers and notify them immediately of the product recall. Customers with questions were instructed to contact BD Customer Service at 1-888-237-2762, option 3. For questions regarding this recall call 518-742-4571.

    Distribution

    Nationwide Distribution

    Quantity

    3 units/pouches