| Class 2 Device Recall Various convenience packs |  |
Date Initiated by Firm | June 16, 2022 |
Create Date | September 08, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1698-2022 |
Recall Event ID |
90574 |
Product Classification |
General surgery tray - Product Code LRO
|
Product | Various 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 |
Action | The 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 Commerce | 116 |
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 |
Total Product Life Cycle | TPLC 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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