Recall archive / FDA device enforcement

Various Angiography/Cath Lab packs/trays — FDA record Z-1690-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 16, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Various Angiography/Cath Lab packs/trays
Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Classification: Class II
Recalling firm: American Contract Systems, Inc.
Quantity: 61 units
Agency-reported status: Ongoing
Source record identifier: Z-1690-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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

Label field

Details supplied by the agency

Lot, code or applicability

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

Match all identifying details in the current notice. A brand name alone is not enough.

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Sep 14, 2022
Recall initiation date: Jun 16, 2022
Center classification date: Sep 8, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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