Various convenience packs
FDA Device Recall #Z-1698-2022 — Class II — June 16, 2022
Recall Summary
| Recall Number | Z-1698-2022 |
| 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 | 116 |
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) LSRICUMXBARB, 2104091, 905211, 14531603 2) LSRBASICPACD, 2104091, 90921+A3:A1061, 14798924 3) LSRCFBVIIIPKE, 2104091, 904211, 14806477 4) LSRBASICPACD, 2105101, 881211, 14880418 5) LSRMAJBASINC, 2106082, 860211, 44252207 6) LSRMAJBASINC, 2106082, 860211, 44251930 7) LSRLATEXTUBA, 2106021, 855211, 63157124 8) LSRULTRASNDE, 2106021, 854211, 63157124 9) LSRGCMAJA, 2106082, 852211, 63989104 10) LSRBASICPACD, 2107151, 812211, 15020877 11) LSRBASICPACD, 2107262, 809211, 44540501 12) LSRBASICPACD, 2107262, 809211, 43967223 13) LSRSMTRAMAA, 2107262, 799211, 64117655 14) LSRBASICPACD, 2108042, 791211, 44140770 15) LSRLMMAJLAPI, 2108251, 779211, 64119586 16) LSRMAJBASINC, 2108251, 775211, 44376071 17) LSRBASICPACD, 2109071, 771211, 15142869 18) LSRBASICPACD, 2109071, 771211, 15142870 19) LSRGENLAPD, 2109071, 764211, 44376119 20) LSRGENLAPD, 2109071, 764211, 44376120 21) LSRULTRASNDE, 2109162, 754211, 64318297 22) LSRCFHSBASD, 2109271, 742211, 44373955 23) LSRCFHSBASD, 2109271, 742211, 44373956 24) LSRMAJBASINC, 2109271, 740211, 44373122 25) LSRBASICPACD, 2109271, 740211, 15142071 26) CFLA39E, 2104072, 904211, 64022736 27) IHCO09AC, 2104143, 897211, 64034271 28) IHCO09AC, 2107061, 818211, 64169033 29) TNBS21M, 2108202, 770211, 15065342 30) TNLO05L, 2108193, 770211, 15065666 31) UILT39AB, 2108231, 770211, 64232963 32) UILT39AB, 2108231, 770211, 64232967 33) TNGN04O, 2109072, 755211, 64225628 34) HJMI20F, 2110053, 723211, 15138551 35) SLBS91E, 2104053, 905211, 44127314-005 36) GILA43G, 2104091, 902211, 44126250-005 37) MESB48F, 2104292, 882211, 14877406-004 38) MEGN04T, 2105182, 862211, 44108485-005 39) CXMN85T, 2105202, 861211, 14858002-004 40) MEBS42J, 2105251, 856211, 14858010-004 41) SCSP05Q, 2105272, 853211, 44132237-005 42) MEBS42J, 2106153, 834211, 15002398-004 43) MEBS42J, 2106153, 834211, 15002443-004 44) MEBS42J, 2106153, 834211, 15002445-004 45) MEBS42J, 2106153, 834211, 15002444-004 46) SHMI41H, 2106162, 833211, 43997356-005 47) MHCV01H, 2106221, 827211, 64114273-006 48) MEGN04T, 2106293, 825211, 43993757-005 49) MEGN04T, 2106293, 825211, 43994199-005 50) MEBS42J, 2107121, 810211, 15014941-004 51) PRAB23T, 2107152, 804211, 64100457-006 52) BLBA12J, 2107203, 799211, 15011598-004 53) SLBS91E, 2107202, 800211, 44236721-005 54) SLBS91E, 2107202, 800211, 44236720-005 55) SLBS91E, 2107202, 800211, 44236719-005 56) SLBS91E, 2107202, 800211, 44236717-005 57) SAMN86X, 2107212, 798211, 44236458-005 58) SCSP05Q, 2107211, 799211, 44236716-005 59) CESB24G, 2107221, 798211, 15011356-004 60) BHMB65J, 2107271, 793211, 15009221-004 61) BHMB65J, 2107271, 793211, 15009222-004 62) BHMB65J, 2107271, 793211, 15009223-004 63) FTGS08, 2108161, 775211, 44239258-005 64) ATLO08Y, 2108201, 769211, 44316563-005 65) JESB11F, 2108302, 758211, 15101885-004 66) MEBS42J, 2108303, 768211, 15101887-004 67) BHMN41J, 2109031, 754211, 44313730-005 68) BLBS07H, 2109011, 757211, 15103550-004 69) MEGN04T, 2109082, 749211, 44320301-005 70) SCSP05Q, 2109082, 749211, 44321323-005 71) CXBS22D, 2109101, 760211, 15109750-004 72) SAMN86, 2109133, 744211, 44318760-005 73) GILA43C, 2109151, 742211, 44318759-005 74) JEMJ10N, 2109211, 737211, 64220359-006 75) LMBS30L, 2109232, 735211, 44316978-005 76) BHMN18D, 2104273, 889211, 44189882-005 77) BHMJ56B, 2104281, 884211, 44196650-005 78) BHMJ56B, 2105212, 866211, 44207947-005 79) BHMN18D, 2107061, 819211, n/a 80) UMBR26A, 2108042, 786211, 44217597-005 81) NCMP74H, 2108053, 785211, 64093497-006 82) BHMN18D, 2108091, 783211, 44216491-005 83) BHMN18D, 2108091, 783211, 44336987-005 84) BHMN18D, 2108091, 783211, 44216657-005 85) BHMN18D, 2108091, 783211, 44216490-005 86) TMMN21A, 2108131, 777211, 64093159-006 87) BHMN18D, 2108181, 777211, 44215916-005 88) BHMN18D, 2108231, 769211, 44336910-005 89) BHMN18D, 2108231, 769211, 44334799-005 90) BHMN18D, 2108231, 769211, 44334800-005 91) BHCI35E, 2108271, 769211, 63999572-006 92) BHMJ56B, 2108281, 763211, 44333493-005 93) BHMJ56B, 2108281, 763211, 44333337-005 94) BHMJ56B, 2108281, 763211, 44333491-005 95) BHMN18D, 2108302, 763211, 44333494-005 96) BHMN18D, 2108302, 763211, 44333490-005 97) BHMN18D, 2108302, 763211, 44333495-005 98) BHMN18D, 2108302, 763211, 44333400-005 99) BHMN18D, 2109031, 761211, 44345692-005 100) BHMN18D, 2109031, 761211, 44345693-005 101) BHMN18D, 2109031, 761211, 44332523-005 102) BHMN18D, 2109071, 754211, 44344591-005 103) BHMN18D, 2109071, 754211, 44344590-005 104) BHMN18D, 2109211, 741211, 44356407-005 105) BHMJ56B, 2109281, 740211, 44353431-005 106) SJMB73E, 2105041, 905211, 14703497-004 107) MPMN55C, 2105281, 877211, 14893780-004 108) SFAB10E, 2106071, 847211, 44042725-005 109) MCMJ52D, 2106301, 823211, 44044534-005 110) SAMB25D, 2107011, 819211, 44173648-005 111) SJMB73E, 2107081, 818211, 15032945-004 112) BHSG01B, 2109131, 748211, 64134902-006 113) SAMB25D, 2109131, 750211, 44260252-005 114) SJMB73E, 2109271, 733211, 15023711-006 115) PWBA40H, 2104081, 905211, 14774080-004 116) JRSU11F, 2105261, 861211, 14575286-004
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.