BEUDAMED
    FDA Recall Open, Classified

    REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO

    Recall: Z-0025-2024 · Initiated August 29, 2023

    Recall

    Recall Number
    Z-0025-2024
    Event Number
    92970
    Firm
    Becton Dickinson Infusion Therapy Systems Inc.
    FEI Number
    1710034
    Product Code
    FOZ
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    August 29, 2023
    Posted
    October 3, 2023
    Address
    9450 S State St, Sandy, UT, 84070-3213

    Description

    REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO

    Reason

    There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminated needle point exposed.

    Action

    On August 29, 2023, Becton Dickinson issued an "Urgent Medical Device Recall" notification via. FedEx. Becton Dickinson asked consignees to take the following actions: 1. Immediately review your inventory for Catalog Number 386862, Lot number 2238464. Destroy all unused product subject to the recall following your institution's process for destruction. 2. For indwelling catheters, no further action is needed. 3. If a defective product was used on a patient and the used needle was disposed of without the clinician suffering a needlestick injury, no further action is necessary to further protect the patient or the clinician. 4. Share this recall notification with all users within your facility network of the product to ensure they are also aware of this recall. 5. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements and subsequently process your product replacement. 6. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch, Phone: 1-800-FDA 1088 (1-800-332-1088), Mail: MedWatch, HF-2, FDA, 5600 Fisher.s Lane, Rockville, MD 20852-978

    Distribution

    US Nationwide distribution in the states of CA, FL, GA, MA, MN, MO, MS, NJ, OH, TX.

    Quantity

    98,000 units