BEUDAMED
    FDA Enforcement Class II Terminated

    Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Number 43056-01; 2) List Number 43023-01; 3) List Number 43025-01; 4) List Number 43025-11; 5) List Number 43025-21; 6) List Number 43025-25; 7) List Number 43038-05; 8) List Number 43043-01; 9) List Number 43044-01; 10) List Number 43044-11; 11) List Number 43046-01; 12) List Number 43047-01; 13) List Number 43041-01; 14) List Number 43024-01; 15) List Number 43027-01; 16) List Number 43027-14; 17) List Number 43001-01; 18) List Number 43064-01; 19) List Number 43046-05; 20) List Number 43042-11; 21) List Number 43042-01; 22) List Number 43044-05; 23) List Number 43044-15

    Recall: Z-2594-2016 · Reported August 24, 2016

    Enforcement

    Recall Number
    Z-2594-2016
    Event ID
    66448
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hospira Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 24, 2016
    Initiation Date
    September 10, 2013
    Classification Date
    August 18, 2016
    Termination Date
    December 15, 2016
    Address
    275 N Field Dr, N/A, Lake Forest, IL, 60045-2579, United States

    Description

    Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Number 43056-01; 2) List Number 43023-01; 3) List Number 43025-01; 4) List Number 43025-11; 5) List Number 43025-21; 6) List Number 43025-25; 7) List Number 43038-05; 8) List Number 43043-01; 9) List Number 43044-01; 10) List Number 43044-11; 11) List Number 43046-01; 12) List Number 43047-01; 13) List Number 43041-01; 14) List Number 43024-01; 15) List Number 43027-01; 16) List Number 43027-14; 17) List Number 43001-01; 18) List Number 43064-01; 19) List Number 43046-05; 20) List Number 43042-11; 21) List Number 43042-01; 22) List Number 43044-05; 23) List Number 43044-15

    Reason

    Hospira has become aware of customers using the incorrect size Receptal liners with their Receptal canisters, e.g., 1.5 L liner, 2L liner or 3L liner with a 1L canister. It is possible that if an incorrectly sized liner is used with a different size canister the lid may not fit and the vacuum/suction will not be sufficient and/or consistent.

    Code Info

    43001-04-01 43023-04-01 43024-04-01 43024-04-62 43025-04-01 43025-04-11 43025-04-21 43025-04-25 43027-04-01 43027-04-05 43027-04-11 43027-04-14 43027-04-17 43031-04-02 43032-04-05 43034-04-06 43036-04-04 43037-04-02 43038-04-04 43038-04-05 43041-04-01 43042-04-01 43042-04-11 43043-04-01 43044-04-01 43044-04-05 43044-04-11 43044-04-15 43044-04-51 43046-04-01 43046-04-05 43047-04-01 43056-04-01 43061-04-01 43062-04-01 43063-04-01 43064-04-01 0L212-01 0L213-01

    Distribution

    *** US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, 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, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY), District of Columbia, Puerto Rico; *** FOREIGN: Australia, Canada, Costa Rica, Singapore, South Africa

    Quantity

    67,410,861 liners and 67,410,861 lids/canisters in total