Summary
The FDA issued a Class II for Various convenience packs by American Contract Systems, Inc.. Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures..
Details
Source
Device Recall
External ID
Z-1698-2022
Action Date
2022-09-14
Status
Ongoing
Category
device
Product Description
Various convenience packs
Lot/Code Info: 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
Quantity Affected: 116
Reason for Recall
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Distribution
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
Type: Voluntary: Firm initiated
Recall Initiated: 2022-06-16
Company
Kansas City, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 134 device recalls issued in the same week, part of 403 device-related FDA actions this month.
American Contract Systems, Inc. has 188 FDA actions in our database, including 188 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (American Contract Systems, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does American Contract Systems, Inc. have FDA actions?
American Contract Systems, Inc. has 188 FDA actions in our database, including 188 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1698-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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