BEUDAMED
    FDA Recall Terminated

    Lube Jelly, 1 oz. water-base sterile lubricating jelly, a component of various Presource Custom Sterile Convenience Packs/Modules; Packaged by Cardinal Health Medical Products and Services, McGaw Park, IL 60085 U.S.A.; The affected lots of modules actually contain a 1 oz. tube of Non-Sterile Kendall Vaseline White Petroleum Jelly. Designed to assist hospitals in preparing for procedures by grouping all of the necessary components used for a procedure in one wrapper.

    Recall: Z-1968-2011 · Initiated February 28, 2011

    Recall

    Recall Number
    Z-1968-2011
    Event Number
    58054
    Firm
    Cardinal Health
    FEI Number
    3001236905
    Product Code
    KMJ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    February 28, 2011
    Posted
    April 13, 2011
    Terminated
    April 19, 2012
    Address
    1430 Waukegan Rd, Mc Gaw Park, IL, 60085-6726

    Description

    Lube Jelly, 1 oz. water-base sterile lubricating jelly, a component of various Presource Custom Sterile Convenience Packs/Modules; Packaged by Cardinal Health Medical Products and Services, McGaw Park, IL 60085 U.S.A.; The affected lots of modules actually contain a 1 oz. tube of Non-Sterile Kendall Vaseline White Petroleum Jelly. Designed to assist hospitals in preparing for procedures by grouping all of the necessary components used for a procedure in one wrapper.

    Reason

    The Presource kits were assembled with non-sterile petroleum base lubricant instead of the labeled sterile water base lubricating jelly.

    Action

    Cardinal Health issued an URGENT: PRODUCT RECALL letter dated February 28, 2011 to all affected consignees via UPS next day air, informing them that their Presource kit/modules listed in the attached spreadsheet contain a non-sterile petroleum-based lubricating jelly instead of the labeled water-based sterile lubricating jelly. Cardinal instructed the accounts to quarantine the pack/modules with the indicated work order/lot number on the enclosed spreadsheet and contact the appropriate Customer Service group listed in the letter for return instructions. The accounts were also requested to complete and fax back to Cardinal the enclosed reply sheet acknowledging receipt of the letter and the number of pack/modules being returned. If the product was further distributed, then those customers should also be notified.

    Distribution

    Nationwide Distribution

    Quantity

    4,236 modules