Various convenience packs
Class I - DangerousWhat Should You Do?
- Check if you have this product: Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRHUMTOTPKC, 2104192, 894211, 14881385 2) LSRLMHANDA, 2104221, 901211, 64119577 3) LSRHUMTOTPKC, 2104192, 894211, 14881385 4) LSRTOTJOINTM, 2104301, 888211, 63993926 5) LSRTOTJOINTM, 2104301, 888211, 63993926 6) LSRLMHANDA, 2105101, 883211, 63991195 7) LSRORTHOMINH, 2107221, 818211, 64119458 8) LSRTOTJOINTM, 2107171, 809211, 64116601 9) LSRTOTJOINTM, 2107171, 809211, 64116600 10) LSRSMANTHF, 2107171, 810211, 64116603 11) LSRARTHROSE, 2108251, 785211, 44139253 12) LSRORTHOMINH, 2108251, 778211, 64119583 13) LSRORTHOMINH, 2108251, 778211, 64119582 14) LSRORTHOMINH, 2109162, 754211, 64318299 15) LSRORTHOMINH, 2109162, 754211, 64318298 16) LSRORTHOMINH, 2109162, 754211, 64318717 17) LSRTOTJOINTM, 2109231, 747211, 64319310 18) LSRORTHOMINH, 2110011, 735211, 64318801 19) MKMA57I, 2104061, 909211, 64024798 20) UICA66AG, 2104122, 902211, 64034679 21) FDPD04AB, 2104143, 901211, 64034128 22) UIEB90G, 2104162, 895211, 14779410 23) UIOS80W, 2106291, 825211, 64170682 24) PCTS17E, 2107192, 803211, 64164240 25) AMTK03AF, 2108162, 776211, 64231145 26) UIKN28AN, 2108202, 771211, 64230570 27) UIHN18AP, 2108193, 771211, 64231011 28) UIHN18AP, 2108193, 771211, 64230951 29) TNTK20U, 2108262, 763211, 64237810 30) LMHN50S, 2109023, 758211, 64234603 31) SCAR03U, 2104151, 895211, 44124761-005 32) BHTK51, 2104191, 891211, 63978560-006 33) SETK12E, 2104261, 887211, 63985987-006 34) SETK12E, 2104261, 887211, 63985736-006 35) FHOM26X, 2104301, 882211, 44123694-005 36) UIOS80V, 2105051, 880211, 63984525-006 37) LOAP10B, 2105102, 870211, 63958629-006 38) SLTH18F, 2105102, 870211, 63958630-006 39) FTHD18I, 2105192, 866211, 63956743-006 40) FAUE10AC, 2105241, 858211, 44133505-005 41) SSTK16F, 2105262, 854211, 63955145-006 42) SHKN28C, 2105271, 854211, 64074676-006 43) FLOR01I, 2106072, 842211, 64074728-006 44) CXOS01T, 2106101, 841211, 44128814-005 45) FHSH28AC, 2107022, 818211, 64112048-006 46) SFAR59E, 2107093, 810211, 44244601-005 47) SLUE07D, 2107101, 809211, 64099712-006 48) AHEX25K, 2107162, 803211, 44244629-005 49) AHEX25K, 2107162, 803211, 44244631-005 50) AHEX25K, 2107162, 803211, 44244630-005 51) AHEX25K, 2107162, 803211, 44244628-005 52) FTHD18I, 2107191, 800211, 64098800-006 53) FTHD18I, 2107191, 800211, 64098798-006 54) FTHD18I, 2107191, 800211, 64098797-006 55) FTHD18I, 2107191, 800211, 64098799-006 56) FHTK32AD, 2107241, 795211, 64097109-006 57) SAOR89Z, 2107292, 791211, 64109976-006 58) FHHP63S, 2108022, 789211, 15007401-004 59) SETK12E, 2108052, 785211, 64107496-006 60) CXHA75H, 2108062, 782211, 15003851-005 61) FAUE10AC, 2108141, 775211, 44239520-005 62) SFAR59E, 2108172, 771211, 44239251-005 63) COPO63, 2108201, 769211, 44316565-005 64) BHLE58G, 2108252, 763211, 44315273-005 65) SFTK53H, 2108313, 757211, 64204506-006 66) CBTJ34H, 2109101, 747211, 64209800-006 67) PREX34U, 2109142, 749211, 64208358-006 68) SAAR74T, 2109162, 741211, 44318763-005 69) MESA11O, 2109211, 741211, 64220362-006 70) FHOM26X, 2109222, 737211, 44316980-005 71) ATTO11J, 2109232, 735211, 64220363-006 72) BHEX32D, 2104291, 894211, 64068954-006 73) BHEX32D, 2104291, 894211, 64068953-006 74) DSEX64D, 2105052, 880211, 14954450-004 75) BHHS55C, 2105191, 883211, 64063386-006 76) BHHD71E, 2105212, 863211, 14974551-004 77) BHAR12C, 2105252, 859211, 64063803-006 78) BHAR12C, 2105252, 859211, 64063802-006 79) BHEX32D, 2106091, 847211, 64045606-006 80) BHEX32D, 2106081, 847211, 64046915-006 81) BHHS55C, 2106082, 848211, 64045553-006 82) UMOR21B, 2106162, 838211, 44210738-005 83) NCTH24J, 2106303, 821211, 64090017-006 84) BHAR12C, 2107091, 820211, 64089228-006 85) BHHS55C, 2107091, 826211, 64088772-006 86) BHHS55C, 2107091, 826211, 64088773-006 87) BHHD26F, 2107221, 803211, 44227720-005 88) BHHD26F, 2107221, 803211, 44227722-005 89) BHHD26F, 2107221, 803211, 44227721-005 90) BHHS55C, 2107271, 798211, 64096266-006 91) BHEX32D, 2108092, 784211, 64094371-006 92) BHEX32D, 2108092, 784211, 64094370-006 93) BHEX32D, 2108092, 784211, 64094201-006 94) BHEX32D, 2108092, 784211, 64094200-006 95) BHEX32D, 2108092, 784211, 64094199-006 96) BHEX32D, 2108092, 784211, 64093655-006 97) BHAR12C, 2108112, 779211, 64093730-006 98) BHAR12C, 2108112, 779211, 64093746-006 99) BHAR12C, 2108112, 779211, 64093745-006 100) BHHS55C, 2108131, 777211, 64093727-006 101) NCTK31J, 2109083, 756211, 63998080-006 102) BHEX32D, 2109141, 748211, 64310593-006 103) BHEX32D, 2109141, 748211, 64310594-006 104) BHEX32D, 2109141, 748211, 64310759-006 105) BHEX32D, 2109141, 748211, 64310592-006 106) BHHS55C, 2109212, 747211, 64310388-006 107) DRSP17A, 2104141, 903211, 63861576-006 108) DRSP17A, 2104141, 903211, 63861575-006 109) SATO27E, 2104091, 904211, 64009103-006 110) WHTK06B, 2106301, 826211, 64130783-006 111) MPKK10B, 2107061, 818211, 64128810-006 112) UTSA18P, 2104271, 888211, 44175244-005 113) UTSA18P, 2104271, 888211, 44175243-005 114) UTSA18P, 2104271, 888211, 44175238-005 115) UTSA18P, 2104271, 888211, 44175235-005 116) GREX13I, 2105041, 877211, 14912665-004 117) AHSC20B, 2107061, 821211, 44167441-005 118) AHKA41C, 2109221, 740211, 64285900-006
- 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 convenience packs
Product Codes/Lot Numbers:
Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRHUMTOTPKC, 2104192, 894211, 14881385 2) LSRLMHANDA, 2104221, 901211, 64119577 3) LSRHUMTOTPKC, 2104192, 894211, 14881385 4) LSRTOTJOINTM, 2104301, 888211, 63993926 5) LSRTOTJOINTM, 2104301, 888211, 63993926 6) LSRLMHANDA, 2105101, 883211, 63991195 7) LSRORTHOMINH, 2107221, 818211, 64119458 8) LSRTOTJOINTM, 2107171, 809211, 64116601 9) LSRTOTJOINTM, 2107171, 809211, 64116600 10) LSRSMANTHF, 2107171, 810211, 64116603 11) LSRARTHROSE, 2108251, 785211, 44139253 12) LSRORTHOMINH, 2108251, 778211, 64119583 13) LSRORTHOMINH, 2108251, 778211, 64119582 14) LSRORTHOMINH, 2109162, 754211, 64318299 15) LSRORTHOMINH, 2109162, 754211, 64318298 16) LSRORTHOMINH, 2109162, 754211, 64318717 17) LSRTOTJOINTM, 2109231, 747211, 64319310 18) LSRORTHOMINH, 2110011, 735211, 64318801 19) MKMA57I, 2104061, 909211, 64024798 20) UICA66AG, 2104122, 902211, 64034679 21) FDPD04AB, 2104143, 901211, 64034128 22) UIEB90G, 2104162, 895211, 14779410 23) UIOS80W, 2106291, 825211, 64170682 24) PCTS17E, 2107192, 803211, 64164240 25) AMTK03AF, 2108162, 776211, 64231145 26) UIKN28AN, 2108202, 771211, 64230570 27) UIHN18AP, 2108193, 771211, 64231011 28) UIHN18AP, 2108193, 771211, 64230951 29) TNTK20U, 2108262, 763211, 64237810 30) LMHN50S, 2109023, 758211, 64234603 31) SCAR03U, 2104151, 895211, 44124761-005 32) BHTK51, 2104191, 891211, 63978560-006 33) SETK12E, 2104261, 887211, 63985987-006 34) SETK12E, 2104261, 887211, 63985736-006 35) FHOM26X, 2104301, 882211, 44123694-005 36) UIOS80V, 2105051, 880211, 63984525-006 37) LOAP10B, 2105102, 870211, 63958629-006 38) SLTH18F, 2105102, 870211, 63958630-006 39) FTHD18I, 2105192, 866211, 63956743-006 40) FAUE10AC, 2105241, 858211, 44133505-005 41) SSTK16F, 2105262, 854211, 63955145-006 42) SHKN28C, 2105271, 854211, 64074676-006 43) FLOR01I, 2106072, 842211, 64074728-006 44) CXOS01T, 2106101, 841211, 44128814-005 45) FHSH28AC, 2107022, 818211, 64112048-006 46) SFAR59E, 2107093, 810211, 44244601-005 47) SLUE07D, 2107101, 809211, 64099712-006 48) AHEX25K, 2107162, 803211, 44244629-005 49) AHEX25K, 2107162, 803211, 44244631-005 50) AHEX25K, 2107162, 803211, 44244630-005 51) AHEX25K, 2107162, 803211, 44244628-005 52) FTHD18I, 2107191, 800211, 64098800-006 53) FTHD18I, 2107191, 800211, 64098798-006 54) FTHD18I, 2107191, 800211, 64098797-006 55) FTHD18I, 2107191, 800211, 64098799-006 56) FHTK32AD, 2107241, 795211, 64097109-006 57) SAOR89Z, 2107292, 791211, 64109976-006 58) FHHP63S, 2108022, 789211, 15007401-004 59) SETK12E, 2108052, 785211, 64107496-006 60) CXHA75H, 2108062, 782211, 15003851-005 61) FAUE10AC, 2108141, 775211, 44239520-005 62) SFAR59E, 2108172, 771211, 44239251-005 63) COPO63, 2108201, 769211, 44316565-005 64) BHLE58G, 2108252, 763211, 44315273-005 65) SFTK53H, 2108313, 757211, 64204506-006 66) CBTJ34H, 2109101, 747211, 64209800-006 67) PREX34U, 2109142, 749211, 64208358-006 68) SAAR74T, 2109162, 741211, 44318763-005 69) MESA11O, 2109211, 741211, 64220362-006 70) FHOM26X, 2109222, 737211, 44316980-005 71) ATTO11J, 2109232, 735211, 64220363-006 72) BHEX32D, 2104291, 894211, 64068954-006 73) BHEX32D, 2104291, 894211, 64068953-006 74) DSEX64D, 2105052, 880211, 14954450-004 75) BHHS55C, 2105191, 883211, 64063386-006 76) BHHD71E, 2105212, 863211, 14974551-004 77) BHAR12C, 2105252, 859211, 64063803-006 78) BHAR12C, 2105252, 859211, 64063802-006 79) BHEX32D, 2106091, 847211, 64045606-006 80) BHEX32D, 2106081, 847211, 64046915-006 81) BHHS55C, 2106082, 848211, 64045553-006 82) UMOR21B, 2106162, 838211, 44210738-005 83) NCTH24J, 2106303, 821211, 64090017-006 84) BHAR12C, 2107091, 820211, 64089228-006 85) BHHS55C, 2107091, 826211, 64088772-006 86) BHHS55C, 2107091, 826211, 64088773-006 87) BHHD26F, 2107221, 803211, 44227720-005 88) BHHD26F, 2107221, 803211, 44227722-005 89) BHHD26F, 2107221, 803211, 44227721-005 90) BHHS55C, 2107271, 798211, 64096266-006 91) BHEX32D, 2108092, 784211, 64094371-006 92) BHEX32D, 2108092, 784211, 64094370-006 93) BHEX32D, 2108092, 784211, 64094201-006 94) BHEX32D, 2108092, 784211, 64094200-006 95) BHEX32D, 2108092, 784211, 64094199-006 96) BHEX32D, 2108092, 784211, 64093655-006 97) BHAR12C, 2108112, 779211, 64093730-006 98) BHAR12C, 2108112, 779211, 64093746-006 99) BHAR12C, 2108112, 779211, 64093745-006 100) BHHS55C, 2108131, 777211, 64093727-006 101) NCTK31J, 2109083, 756211, 63998080-006 102) BHEX32D, 2109141, 748211, 64310593-006 103) BHEX32D, 2109141, 748211, 64310594-006 104) BHEX32D, 2109141, 748211, 64310759-006 105) BHEX32D, 2109141, 748211, 64310592-006 106) BHHS55C, 2109212, 747211, 64310388-006 107) DRSP17A, 2104141, 903211, 63861576-006 108) DRSP17A, 2104141, 903211, 63861575-006 109) SATO27E, 2104091, 904211, 64009103-006 110) WHTK06B, 2106301, 826211, 64130783-006 111) MPKK10B, 2107061, 818211, 64128810-006 112) UTSA18P, 2104271, 888211, 44175244-005 113) UTSA18P, 2104271, 888211, 44175243-005 114) UTSA18P, 2104271, 888211, 44175238-005 115) UTSA18P, 2104271, 888211, 44175235-005 116) GREX13I, 2105041, 877211, 14912665-004 117) AHSC20B, 2107061, 821211, 44167441-005 118) AHKA41C, 2109221, 740211, 64285900-006
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-1699-2022
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American Contract Systems
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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.