BEUDAMED
    FDA Recall Terminated

    LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira Product Usage: For use in transurethral resection procedures

    Recall: Z-1624-2014 · Initiated March 25, 2014

    Recall

    Recall Number
    Z-1624-2014
    Event Number
    68129
    Firm
    Hospira Inc.
    FEI Number
    3013319212
    Product Code
    GBX
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    March 25, 2014
    Posted
    May 16, 2014
    Terminated
    December 6, 2016
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579

    Description

    LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira Product Usage: For use in transurethral resection procedures

    Reason

    The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lea

    Action

    Hospira sent an URGENT MEDICAL DEVICE RECALL letter dated March 25, 2014 to all affected customers. The letter included instructions for the direct accounts to: 1) check their inventories and quarantine any of the affected products; 2) complete and return the attached reply form to the fax number or e-mail address on the form; 3) inform potential users of these products of this recall; 4) return the affected products to Stericycle using the labels provided with the letter (additional labels or reply forms can be obtained by calling Stericycle at 877-377-5128, Monday - Friday, 8:00 AM - 5:00 PM EST); and, 5) if the products were further distributed, notify those customers and request that they contact Stericycle at 877-377-5128 (Monday - Friday, 8:00 AM - 5:00 PM EST). An updated URGENT MEDICAL DEVICE RECALL letter dated March 28, 2014 was sent to all affected customers. The letter contained instructions similar to those found in the March 25, 2014 letter.

    Distribution

    Worldwide Distribution - US: Nationwide in the states of (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, UT, WA, WI, WV, WY) including District of Columbia and Puerto Rico; *** the countries of Barbados, Canada, Costa Rica, Dominican Republic, Hong Kong, Kuwait, Libya, Saudi Arabia, United Arab Emirates

    Quantity

    1,109,321 set (US); 15,113 sets (Foreign)