BEUDAMED
    FDA Recall Terminated

    Prostate Seeding Needle for Use with the Mick Applicator; an 18 gauge needle, 17 cm long with a white molded plastic hub. The non-sterile prostate seeding needles were shipped in bulk for packaging, sterilization and distribution by the customers; the bulk packages were labeled as follows: a) part no. B0140268, Prostate Seeding Set, MICK, InterV - Wheeling, Wheeling, IL 60090 and b) part no. 2380US-18E-17, 18GA x 17CM MK Prostate Seeding Nee, InterV - WHeeling, WHeeling, IL 60090

    Recall: Z-0922-05 · Initiated May 3, 2005

    Recall

    Recall Number
    Z-0922-05
    Event Number
    31963
    Firm
    Manan Medical Products, Inc.
    FEI Number
    1417485
    Product Code
    KXK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 3, 2005
    Posted
    June 22, 2005
    Terminated
    August 29, 2005
    Address
    241 W Palatine Rd, Wheeling, IL, 60090-5824

    Description

    Prostate Seeding Needle for Use with the Mick Applicator; an 18 gauge needle, 17 cm long with a white molded plastic hub. The non-sterile prostate seeding needles were shipped in bulk for packaging, sterilization and distribution by the customers; the bulk packages were labeled as follows: a) part no. B0140268, Prostate Seeding Set, MICK, InterV - Wheeling, Wheeling, IL 60090 and b) part no. 2380US-18E-17, 18GA x 17CM MK Prostate Seeding Nee, InterV - WHeeling, WHeeling, IL 60090

    Reason

    The hub of the prostate seeding needle does not release as expected from the applicator as expected during procedures.

    Action

    Manan Medical sent recall letters to their bulk needle customers on 5/3/05, informing them of Mick Radio-Nuclear''s recall of their Prostate Seeding Needles manufactured by Manan due to the out of specification needle hub sticking in the applicator. The accounts were informed that the needles manufactured for them were made using the same mold as the Mick needle, and were requested to return the affected lot numbers to Manan for replacement.

    Distribution

    Florida and Georgia

    Quantity

    22,900 units