BEUDAMED
    FDA Recall Terminated

    EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905280, 14.5 Fr. Alphacurve Catheter with Standard Kit, 28cm length, BARD, UDI# 00801741013812

    Recall: Z-2370-2019 · Initiated May 31, 2019

    Recall

    Recall Number
    Z-2370-2019
    Event Number
    83337
    Firm
    Bard Peripheral Vascular Inc
    FEI Number
    2020394
    Product Code
    MSD
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    May 31, 2019
    Terminated
    May 17, 2022
    Address
    1625 W 3rd St, Bldg 1, Tempe, AZ, 85281-2438

    Description

    EQUISTREAM LONG-TERM HEMODIALYSIS CATHETER, REF/Product code:5905280, 14.5 Fr. Alphacurve Catheter with Standard Kit, 28cm length, BARD, UDI# 00801741013812

    Reason

    The action is being initiated due to complaints received concerning the molded tip of the tunneler breaking or is damaged during the placement procedure of the catheter.

    Action

    Bard Peripheral Vascular, Inc. (BPV) mailed a recall letter on May 23, 2019 to each of the US consignees via FedEx with proof of delivery notification. BPV is also issuing customer notifications for product outside the US in accordance with regulations of each country in which the product was distributed. The recall letter asked consignees to do the following: 1. Do not use or further distribute any affected product. 2. Please check all inventory locations within your institution for affected product code / lot number combinations listed in the recall notice. If you have further distributed any of the product code / lot numbers, please immediately contact that location, advise them of the recall, forward these instructions and have them return the affected product to BPV. 3. Please remove any identified product from your shelves. 4. If you have used the affected product, complete and return the attached Recall and Effectiveness Check Form indicating no product will be returned. Once the product affected by this recall has been removed from your inventory: 5. Fill out the Recall and Effectiveness Check Form. Be sure to state the quantities and lot numbers of each recalled product that you intend to return. It is extremely important that we receive this information. 6. Please call our BPV Customer Support Center at 1-800-321-4254 Option #5 (M-F 5am to 2pm MST) or email at [email protected]. Once all information has been verified, the BPV Customer Support Center will issue you a Return Authorization (XC) Number to facilitate the expedient return of the product. BPV will issue a replacemnt product for your returned product. 7. Email the completed Recall and Effectiveness Check Form to [email protected] or fax it to BPV at 1-800-994-6772. If you cannot email or FAX the form, please call the BPV Customer Support Center at 1-800-321-4254 Option #5 and report the required information verbally. 8. A mailing labe

    Distribution

    US: 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, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY OUS: Australia, Canada,

    Quantity

    40 units