BEUDAMED
    FDA Recall Open, Classified

    Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter Repair Kit 0601620 6.6F Broviac CV Catheter Repair Kit 0601630 9.6F Hickman CV Catheter Repair Kit 0601680 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601690 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601700 9F Hickman CV Catheter Repair Kit 0601710 12F Hickman CV Catheter Repair Kit 0601730 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601740 12.5F Hickman CV Catheter Repair Kit 0601750 10F Leonard CV Catheter Repair Kit 0601760 7F Hickman CV Catheter Repair Kit 0601790 10F Hickman CV Catheter Repair Kit

    Recall: Z-1051-2023 · Initiated January 4, 2023

    Recall

    Recall Number
    Z-1051-2023
    Event Number
    91327
    Firm
    Bard Peripheral Vascular Inc
    FEI Number
    2020394
    Product Code
    LJS
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    January 4, 2023
    Posted
    February 1, 2023
    Address
    1625 W 3rd St, Bldg 1, Tempe, AZ, 85281-2438

    Description

    Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV Catheter Repair Kit 0601620 6.6F Broviac CV Catheter Repair Kit 0601630 9.6F Hickman CV Catheter Repair Kit 0601680 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601690 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601700 9F Hickman CV Catheter Repair Kit 0601710 12F Hickman CV Catheter Repair Kit 0601730 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F) 0601740 12.5F Hickman CV Catheter Repair Kit 0601750 10F Leonard CV Catheter Repair Kit 0601760 7F Hickman CV Catheter Repair Kit 0601790 10F Hickman CV Catheter Repair Kit

    Reason

    Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).

    Action

    On 01/04/2023, the firm sent an "URGENT MEDICAL DEVICE RECALL" Letter via FedEx or email to customers informing them that the firm has received complaints regarding hardened/coagulated adhesive associated with various Catheter Repair Kits. as a result of the hardened/coagulated adhesive, there is the potential to cause delays whilst an alternative repair kit, adhesive or replacement catheter is obtained, therefore potentially prolonging surgery or necessitating exchange. Customer are instructed to: 1. Discontinue use of product listed in Attachment A, and immediately dispose of all affected product remaining in their possession in accordance with their local facility s process. 2. Share this notification with all users within their facility network of the product to ensure they are also aware of this field action. 3. If customers purchased this product from a distributor, contact the distributor for further instructions and credit resolution. 4. Complete and return the attached Customer Response Form and return it to the BD contact noted on the form whether or not they have any of the product so that BD may acknowledge their receipt of this notification and subsequently process any applicable credit regarding impacted product. 5. Indicate on the response form the quantity of product identified at their facility and confirm that this product inventory was disposed of. For Distributors (in addition to the above): Identify all customers within their distribution network that purchased any affected product and provide a copy of the attached customer letter to all customers to advise them of this field action notification on BD s behalf. Contact their BD representative if they require assistance with this process or they may also contact the number below for further assistance. North American Regional Complaint Center Phone: 1-844-8BD- LIFE (1-844-823-5433) Say Recall when prompted M-F 8am - 5pm CT Email: [email protected]

    Distribution

    Worldwide Distribution: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; OUS (foreign) countries of: Australia, Belgium, Canada, Hong Kong and Japan. O.U.S.: Australia, Belgium, Canada, Hong Kong, and Japan.

    Quantity

    7520 (Breakdown: US 3764; OUS 3243)