BEUDAMED
    FDA Recall Terminated

    Integra Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable pouch. Vials of 1 % Lidocaine HCL Injection, USP, 10 mg/mL (manufactured and distributed by Hospira Inc.) are placed in a separate sealed pouch. After the bone marrow biopsy pouch is sterilized, a Lidocaine pouch is affixed to each. Ten of these pouches are inserted in a sealed and labeled corrugated box.

    Recall: Z-0193-2016 · Initiated September 22, 2015

    Recall

    Recall Number
    Z-0193-2016
    Event Number
    72274
    Firm
    Integra LifeSciences Corp. d.b.a. Integra Pain Management
    FEI Number
    1000138491
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    September 22, 2015
    Posted
    October 30, 2015
    Terminated
    January 29, 2016
    Address
    3498 West 2400 South, # 1050, Salt Lake City, UT, 84119

    Description

    Integra Bone Marrow Biopsy Trays Catalogue No. 3404253 Various medical devices and components used to perform bone marrow biopsies are placed in a plastic tray which is sealed in an EtO sterilizable pouch. Vials of 1 % Lidocaine HCL Injection, USP, 10 mg/mL (manufactured and distributed by Hospira Inc.) are placed in a separate sealed pouch. After the bone marrow biopsy pouch is sterilized, a Lidocaine pouch is affixed to each. Ten of these pouches are inserted in a sealed and labeled corrugated box.

    Reason

    Integra received an Urgent Drug Recall Notice from Hospira Inc. for their 1% Lidocaine HCL Injection, USP, 10 mg/mL, Lot 44-359-DK. Hospira Inc. is recalling vials of Lot 44-359-DK, 1% Lidocaine HCL Injection, USP, 10 mg/mLm distributed by Hospira from February 2015 to March 2015 due to a confirmed complaint of visible, partially embedded particulate within a single-dose glass teartop vial.

    Action

    Integra sent an Urgent Medical Device / Drug Recall Notice dated September 22, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed.to forward copies of the Integra and Hospira recall notification letters to their customers. Confirmation of recall notification delivery and instructed to stop use of devices and return to Integra. If you have questions of a customer service nature or beyond the information in the Hospira Inc. URGENT DRUG PRODUCT RECALL NOTICE, please contact either your local Integra Pain Management Sales Representative or customer service at 1-800-241-2210.

    Distribution

    US Distributed to the state of : MD.

    Quantity

    A total of 470 packages (47 cases)