BEUDAMED
    FDA Recall Terminated

    Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF 43304. A single catheter in a thermoformed tray with a Tyvek lid. The lidded tray is packaged one per carton. Firm on label: Tyco Healthcare, Mansfield, MA. Product sold sterile, 10 units per case.

    Recall: Z-0932-05 · Initiated April 27, 2005

    Recall

    Recall Number
    Z-0932-05
    Event Number
    32022
    Firm
    Kendall Healthcare Products Co
    FEI Number
    1282497
    Product Code
    LJS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 27, 2005
    Posted
    June 25, 2005
    Terminated
    June 27, 2005
    Address
    15 Hampshire St, Mansfield, MA, 02048-1113

    Description

    Tyco Healthcare Kendall Argyle Neonatal Pediatric PICC, 1.9 Fr/Ch x 30 cm Dual Lumen PICC Catheter, REF 43304. A single catheter in a thermoformed tray with a Tyvek lid. The lidded tray is packaged one per carton. Firm on label: Tyco Healthcare, Mansfield, MA. Product sold sterile, 10 units per case.

    Reason

    Holes in thermoformed tray compromising the sterility of the product.

    Action

    Visits by Tyco Sales Reps on 4/27 & 28/2005.

    Distribution

    Product shipped to hospitals in AZ, CA, IL, IN, NY, and TX.

    Quantity

    120 units