BEUDAMED
    FDA Recall Terminated

    Porex Nostril Retainers, CAT #7241, Size 4, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA.

    Recall: Z-1515-06 · Initiated July 11, 2006

    Recall

    Recall Number
    Z-1515-06
    Event Number
    36172
    Firm
    Porex Surgical, Inc.
    FEI Number
    1000131961
    Product Code
    LYA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 11, 2006
    Posted
    September 22, 2006
    Terminated
    February 6, 2007
    Address
    15 Dart Rd, Newnan, GA, 30265-1017

    Description

    Porex Nostril Retainers, CAT #7241, Size 4, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA.

    Reason

    Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material

    Action

    Consignees were contacted by phone for product return and with a follow up in letter dated 07/12/2006.

    Distribution

    Worldwide distribution ---- including states of AZ, CA, CT, DC, FL, NC, PA, WI and country of Germany. AZ, CA, CT, DC, FL, NC, PA, WI and Germany

    Quantity

    27 units