BEUDAMED
    FDA Enforcement Class II Ongoing

    Various Angiography/Cath Lab packs/trays

    Recall: Z-1690-2022 · Reported September 14, 2022

    Enforcement

    Recall Number
    Z-1690-2022
    Event ID
    90574
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    American Contract Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 14, 2022
    Initiation Date
    June 16, 2022
    Classification Date
    September 8, 2022
    Address
    2610 Ne Industrial Dr Ste 220, N/A, Kansas City, MO, 64117-2648, United States

    Description

    Various Angiography/Cath Lab packs/trays

    Reason

    Product was exposed to multiple sterilization cycles without validation for multiple exposures.

    Code Info

    Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRCUSTCATHG,2104091, 911211, 44064504 2) LSRCARDCATHG,2105191, 874211, 14884701 3) LSRCARDCATHG,2106031, 861211, 14887382 4) LSRCFHCATHD,2106151, 839211, 14887387 5) LSRCARDCATHG,2106172, 842211, 14882944 6) LSRCARDCATHG,2106172, 842211, 14887386 7) LSRCUSTCATHG,2106181, 840211, 44251069 8) LSRCFHCATHD,2107102, 810211, 15020227 9) LSRCFHCATHD,2107102, 810211, 15020826 10) LSRCFHCATHD,2107262, 807211, 15020266 11) LSRSPECPROCF,2107262, 803211, 64117654 12) LSRCARDCATHG,2108171, 783211, 44139783 13) LSRCFHCATHD,2109071, 765211, 44376128 14) LSRCFHCATHD,2109071, 765211, 44376127 15) LSRCFHCATHD,2109071, 765211, 44376129 16) LSRCFHCATHD,2109071, 765211, 44376130 17) LSRCUSTCATHG,2109201, 754211, 44373704 18) LSRCFHCATHD,2109271, 740211, 15142078 19) MMCC14D,2104143, 898211, 64033893 20) IHCC03R,2107061, 819211, 44183402 21) HGCL69G,2107202, 803211, 15053840 22) UIRD89AE,2107293, 793211, 44181939 23) AMCL05M,2108131, 777211, 64230198 24) HGCL69G,2108313, 761211, 15062583 25) SHCA31I,2105142, 866211, 44111393-005 26) CXDP36N,2105241, 858211, 14854252-004 27) SHCA31I,2105261, 855211, 44131698-005 28) BLCL72K,2106141, 835211, 14994491-004 29) SACL75AK,2106212, 828211, 64071585-006 30) MECL20V,2107292, 805211, 44235192-005 31) SACL75AK,2107302, 789211, 64109974-006 32) SLBT02H,2108051, 784211, 44234510-005 33) AHCC27X,2109092, 748211, 64209383-006 34) BHCA49I,2107161, 817211, 44228705-005 35) BHCA49I,2107161, 817211, 44228708-005 36) SHCC17E,2107292, 793211, 44219151-005 37) SHIR38E,2108192, 721211, 14977781-004 38) BHCA49I,2108241, 768211, 44215236-005 39) BHCA49I,2108241, 768211, 44335430-005 40) BHCA49I,2108241, 768211, 44336206-005 41) TMCC25I,2108312, 764211, 63999207-006 42) TMCC25I,2108312, 764211, 63999208-006 43) TMCC25I,2108312, 764211, 63999206-006 44) TMCC25I,2108312, 764211, 63999205-006 45) TMCC25I,2108312, 764211, 63999204-006 46) SHDW24G,2109071, 754211, 44344585-005 47) SHDW24G,2109071, 754211, 44344586-005 48) SHDW24G,2109071, 754211, 44344587-005 49) SHDW24G,2109071, 754211, 44344588-005 50) SHDW24G,2109071, 754211, 44344589-005 51) MPCA63J,2104141, 917211, 64008477-006 52) SJCH22F,2106141, 840211, 64133201-006 53) MCCP02G,2106151, 838211, 64131832-006 54) WHAC86C,2106161, 835211, 64132953-006 55) MCCP02G,2107231, 798211, 64141288-006 56) SNCP60F,2108041, 788211, 64141247-006 57) MCCP02G,2109131, 753211, 64134924-006 58) MCCP02G,2109131, 753211, 64135604-006 59) FBHC45H,2105131, 870211, 14576957-004 60) AGLH66F,2106241, 834211, 44167857-005 61) AGLH66G,2108251, 765211, 44288730-005

    Distribution

    Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX

    Quantity

    61 units