BEUDAMED
    FDA Recall Terminated

    Centurion PICC : CVI2650 ANGIO TRAY CVI3610 CENTRAL LINE INSERTION BUNDLE CVI4025 PICC INSERTION BUNDLE (P/S) CVI4190 CENTRAL LINE INSERTION BUNDLE CVI4190 CENTRAL LINE INSERTION BUNDLE CVI4330 PICC INSERTION TRAY CVI4340 MIDLINE INSERTION TRAY CVI4485 MOUNT SINAI CVP INSERTION KIT CVI515 VENOUS ACCESS KIT CVI650 INSERTION TRAY

    Recall: Z-1045-2020 · Initiated December 11, 2019

    Recall

    Recall Number
    Z-1045-2020
    Event Number
    84530
    Firm
    Centurion Medical Products Corporation
    FEI Number
    3008403546
    Product Code
    OFF
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    December 11, 2019
    Terminated
    September 4, 2020
    Address
    100 Centurion Way, Williamston, MI, 48895-9086

    Description

    Centurion PICC : CVI2650 ANGIO TRAY CVI3610 CENTRAL LINE INSERTION BUNDLE CVI4025 PICC INSERTION BUNDLE (P/S) CVI4190 CENTRAL LINE INSERTION BUNDLE CVI4190 CENTRAL LINE INSERTION BUNDLE CVI4330 PICC INSERTION TRAY CVI4340 MIDLINE INSERTION TRAY CVI4485 MOUNT SINAI CVP INSERTION KIT CVI515 VENOUS ACCESS KIT CVI650 INSERTION TRAY

    Reason

    Incomplete seals on the sterile package may compromise the sterility

    Action

    Centurion issued a notification emailed to Medline Industries, Centurion's parent company. Centurion issued mailing letters via First Class Mail beginning on 12/12/2019, letter states reason for recall, health risk and action to take: Please identify all inventory that you have within your possession and segregate it in a location where it cannot be accessed for use. 2) If you have transferred possession of this product to another individual, to another department or to another location in your organization, you are required by FDA regulations to notify them of this recall communication. Please ask that any affected product be returned to you for collection. 3) Affected product is not to be returned to Centurion, and should be destroyed/discarded. Document the destruction of all product on the enclosed accountability record. 4) Please complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter, Director of Quality Assurance Centurion Medical Products Corporation, (517) 546-5400 Ext.1122.

    Distribution

    Nationwide Foreign: GHANA

    Quantity

    29020