CLASS II ONGOING Device recall · Reported 14 Sep 2022 · FDA Enforcement Report

Various convenience packs recalled by American Contract Systems

American Contract Systems is recalling Various convenience packs, distributed in 13 states. The recall was initiated on 16 Jun 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesTray 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

Quantity recalled118 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1699-2022
FDA event ID: 90574
Recalling firm: American Contract Systems, Kansas City, MO
Classification: Class II
Status: Ongoing
Recall initiated: 16 Jun 2022
FDA classified: 8 Sep 2022
Reported: 14 Sep 2022
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Sterility
Device type: Other Medical Devices

Timeline

16 Jun 2022	Recall initiated by company
8 Sep 2022	Classified by FDA	+84 days
14 Sep 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Various convenience packs

Where it was distributed

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

Arizona Florida Iowa Illinois Massachusetts Minnesota Missouri Nebraska Ohio Pennsylvania Rhode Island South Dakota Texas

Questions about this recall

Is Various convenience packs recalled?

Yes. American Contract Systems recalled Various convenience packs on 16 Jun 2022. The recall is Class II and its status is Ongoing. Recall number Z-1699-2022.

Why was it recalled?

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

Which lots are affected?

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

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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