BEUDAMED
    FDA Recall Terminated

    Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter

    Recall: Z-0199-2023 · Initiated February 24, 2021

    Recall

    Recall Number
    Z-0199-2023
    Event Number
    90981
    Firm
    Access Vascular, Inc.
    FEI Number
    3021570645
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    February 24, 2021
    Posted
    November 8, 2022
    Terminated
    May 30, 2024
    Address
    749 Middlesex Tpke, Billerica, MA, 01821-3906

    Description

    Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter

    Reason

    Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package.

    Action

    Beginning February 24, 2021, the firm notified its affected consignees via Email. Customers were informed that if product had already been used, then no action was required, because all components were still within their expiration date at the time, and no patient safety risk was identified. If product had not been used, customers were asked to refrain from using product until a replacement Scalpel and Statlock were provided.

    Distribution

    Domestic distribution to NC, RI, NJ, and IL. No foreign distribution.

    Quantity

    79 kits