Various convenience packs
FDA Device Recall #Z-1699-2022 — Class II — June 16, 2022
Recall Summary
| Recall Number | Z-1699-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 16, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | American Contract Systems, Inc. |
| Location | Kansas City, MO |
| Product Type | Devices |
| Quantity | 118 units |
Product Description
Various convenience packs
Reason for Recall
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Distribution Pattern
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
Lot / Code Information
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
Other Recalls from American Contract Systems, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1916-2025 | Class II | LOWER EXTREMITY, Model: NCEX20I; LOWER EXTREM... | Apr 21, 2025 |
| Z-1426-2025 | Class II | Brand Name: Banner University Med Ctr. Produ... | Jan 31, 2025 |
| Z-1425-2025 | Class II | Brand Name: Banner Health Systems Product Name... | Jan 31, 2025 |
| Z-1424-2025 | Class II | Brand Name: Banner Health Systems Product Name... | Jan 31, 2025 |
| Z-3244-2024 | Class II | Pacemaker, COPM11B; Medical convenience kit | Aug 7, 2024 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.