Various Angiography/Cath Lab packs/trays
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- American Contract Systems, Inc.
- Reason for Recall:
- Product was exposed to multiple sterilization cycles without validation for multiple exposures.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Various Angiography/Cath Lab packs/trays
Product Codes/Lot Numbers:
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:
Distributed in: AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, TX
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1690-2022
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American Contract Systems
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American Contract Systems
Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.