BEUDAMED
    FDA Recall Terminated

    Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204. Vascular Solutions, 6464 Sycamore Court, Minneapolis, MN 53369.

    Recall: Z-1592-2010 · Initiated February 8, 2010

    Recall

    Recall Number
    Z-1592-2010
    Event Number
    54680
    Firm
    Galt Medical Corp
    FEI Number
    3000718472
    Product Code
    DRE
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    February 8, 2010
    Posted
    May 11, 2010
    Terminated
    March 21, 2011
    Address
    2220 Merritt Dr, Garland, TX, 75041-6137

    Description

    Micro Introducer Kit 5F, Model number: KIT-014-29, & Customer Model number: 7204. Vascular Solutions, 6464 Sycamore Court, Minneapolis, MN 53369.

    Reason

    Potential problem with pouch seal thus affecting sterile product.

    Action

    Firm notified distributor by telephone 2/8/2010. Firm and distributor partnered to notify customers by an Urgent: Medical Device Recall - Lot Specific letter, dated 2/10/2010, beginning 2/16/2010. The letter identified the affected product and the reason for the recall. The letter asked customers to immediately check their inventory remove any affected kits and place them in a secure location. Customers are to complete the Product Recall Inventory Form and fax it to the Customer Service Department. Customers are also to contact Customer Service for a Return Authorization Number at 1-866-240-6001. Affected products will be replaced upon receipt. Questions or concerns should be directed to a local Sales Representative or Jill Eisenzimmer, Product Manager, at 763-656-4300.

    Distribution

    Nationwide Distribution -- MI, PA, IL, & Washington, D.C.

    Quantity

    400 units