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U.S. Department of Health and Human Services

Class 2 Device Recall Various convenience packs

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 Class 2 Device Recall Various convenience packssee related information
Date Initiated by FirmJune 16, 2022
Create DateSeptember 08, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1698-2022
Recall Event ID 90574
Product Classification General surgery tray - Product Code LRO
ProductVarious convenience packs
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
Recalling Firm/
Manufacturer
American Contract Systems, Inc.
2610 Ne Industrial Dr Ste 220
Kansas City MO 64117-2648
For Additional Information Contact
816-920-5846
Manufacturer Reason
for Recall
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
FDA Determined
Cause 2
Process change control
ActionThe recalling firm began notifying customers of the recall beginning June 13, 2022. Customer notification was initially made via email and an "Urgent Medical Device Recall" letter dated June 16, 2022. Customers are asked to review inventory and segregate affected product, which should be identified with the Bag Serial Number. Affected product should be destroyed, with evidence of destruction provided back to the recalling firm. A Field Action Response Form should be completed and returned to angela.bunn@owens-minor.com as soon as possible, even if the customer has no inventory. If you have any questions, please call 816-920-5846.
Quantity in Commerce116
DistributionDistribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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