| | Class 1 Device Recall GE Healthcare OmniBed Carestation CS1 |  |
| Date Initiated by Firm | June 06, 2023 |
|---|
| Date Posted | October 31, 2024 |
|---|
| Recall Status1 |
Completed |
| Recall Number | Z-0140-2025 |
|---|
| Recall Event ID |
95456 |
| 510(K)Number | K152814 K213551 |
|---|
| Product Classification |
Incubator, neonatal - Product Code FMZ
|
| Product | GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model Numbers:
1) 2082844-001-01040418;
2) 2082844-001-01046784;
3) 2082844-001-01052324;
4) 2082844-001-01052572;
5) 2082844-001-01055337;
6) 2082844-001-01065693;
7) 2082844-001-01069008;
8) 2082844-001-01073750;
9) 2082844-001-01086553;
10) 2082844-001-01089393;
11) 2082844-001-01090414;
12) 2082844-001-01092632;
13) 2082844-001-01111482;
14) 2082844-001-01115741;
15) 2082844-001-01122391;
16) 2082844-001-01128579;
17) 2082844-001-01128725;
18) 2082844-001-01131573;
19) 2082844-001-01140642;
20) 2082844-001-01165870;
21) 2082844-001-100397;
22) 2082844-001-100676;
23) 2082844-001-100740;
24) 2082844-001-100743;
25) 2082844-001-100744;
26) 2082844-001-101075;
27) 2082844-001-101149;
28) 2082844-001-101199;
29) 2082844-001-101202;
30) 2082844-001-101203;
31) 2082844-001-101356;
32) 2082844-001-101366;
33) 2082844-001-101656;
34) 2082844-001-102136;
35) 2082844-001-102589;
36) 2082844-001-102858;
37) 2082844-001-526493;
38) 2082844-001-533346;
39) 2082844-001-570904;
40) 2082844-001-615985;
41) 2082844-001-616544;
42) 2082844-001-674814;
43) 2082844-001-701655;
44) 2082844-001-704407;
45) 2082844-001-709042;
46) 2082844-001-857748;
47) 2082844-001-888278;
48) 2082844-001-941288;
49) 2082844-001-965539;
50) 2082844-001-978713;
51) 2082844-001-982099;
52) 2082844-001-982310;
53) 2082844-001-982985;
54) 2082844-001-982988;
55) 2082844-001-983509;
56) 2082844-001-983643;
57) 2082844-001-983679;
58) 2082844-001-984096;
59) 2082844-001-984948;
60) 2082844-001-987480;
61) 2082844-001-987855;
62) 2082844-001-993967;
63) 2082844-001-994441;
64) 2082844-001-995782;
65) 2082844-001-998377; Radiant infant warmer |
|---|
| Code Information |
1) 2082844-001-01040418, UDI: (01)00840682116862(21)TABC70024(11)230203, (01)00840682116862(21)TABC70035(11)230207, (01)00840682116862(21)TABC70037(11)230207, (01)00840682116862(21)TABC70038(11)230207, (01)00840682116862(21)TABC70045(11)230208, (01)00840682116862(21)TABC70052(11)230209, (01)00840682116862(21)TABC70054(11)230209, (01)00840682116862(21)TABC70056(11)230209, (01)00840682116862(21)TABC70060(11)230209, (01)00840682116862(21)TABC70064(11)230210, (01)00840682116862(21)TABC70068(11)230210, (01)00840682116862(21)TABC70069(11)230210, (01)00840682116862(21)TABC70070(11)230210;
2) 2082844-001-01046784, UDI: (01)008406821168622(21)TAB23060007SA(11)230209, (01)008406821168622(21)TAB23060008SA(11)230209, (01)008406821168622(21)TAB23060009SA(11)230209, (01)008406821168622(21)TAB23060010SA(11)230209, (01)008406821168622(21)TAB23060011SA(11)230209, (01)008406821168622(21)TAB23060012SA(11)230209, (01)008406821168622(21)TAB23060013SA(11)230209, (01)008406821168622(21)TAB23060014SA(11)230209, (01)008406821168622(21)TAB23060015SA(11)230209;
3) 2082844-001-01052324, UDI: (01)00840682116862(21)TABC70169(11)230228;
4) 2082844-001-01052572, UDI: (01)00840682116862(21)TABC70101(11)230215, (01)00840682116862(21)TABC70119(11)230217, (01)00840682116862(21)TABC70130(11)230220, (01)00840682116862(21)TABC70136(11)230221, (01)00840682116862(21)TABC70138(11)230222, (01)00840682116862(21)TABC70171(11)230301, (01)00840682116862(21)TABC70180(11)230302, (01)00840682116862(21)TABC70196(11)230306, (01)00840682116862(21)TABC70269(11)230315, (01)00840682116862(21)TABC70270(11)230316, (01)00840682116862(21)TABC70271(11)230316;
5) 2082844-001-01055337, UDI: (01)00840682116862(21)TABC70189(11)230303;
6) 2082844-001-01065693, UDI: (01)00840682116862(21)TABC70349(11)230410;
7) 2082844-001-01069008, UDI: (01)008406821168622(21)TAB23090049SA(11)230304, (01)008406821168622(21)TAB23090050SA(11)230304, (01)008406821168622(21)TAB23090051SA(11)230304, (01)008406821168622(21)TAB23090052SA(11)230304;
8) 2082844-001-01073750, UDI: (01)00840682116862(21)TABC70104(11)230215, (01)00840682116862(21)TABC70190(11)230303, (01)00840682116862(21)TABC70197(11)230306;
9) 2082844-001-01086553, UDI: (01)008406821168622(21)TAB23020017SA(11)230110, (01)008406821168622(21)TAB23020018SA(11)230110, (01)008406821168622(21)TAB23020019SA(11)230110, (01)008406821168622(21)TAB23020020SA(11)230110;
10) 2082844-001-01089393, UDI: (01)00840682116862(21)TABC70289(11)230320, (01)00840682116862(21)TABC70293(11)230322, (01)00840682116862(21)TABC70299(11)230322, (01)00840682116862(21)TABC70307(11)230323, (01)00840682116862(21)TABC70309(11)230324, (01)00840682116862(21)TABC70310(11)230324, (01)00840682116862(21)TABC70314(11)230327, (01)00840682116862(21)TABC70316(11)230328, (01)00840682116862(21)TABC70320(11)230328, (01)00840682116862(21)TABC70321(11)230328, (01)00840682116862(21)TABC70323(11)230329, (01)00840682116862(21)TABC70327(11)230330, (01)00840682116862(21)TABC70328(11)230330, (01)00840682116862(21)TABC70329(11)230330, (01)00840682116862(21)TABC70335(11)230405, (01)00840682116862(21)TABC70337(11)230405, (01)00840682116862(21)TABC70338(11)230405, (01)00840682116862(21)TABC70339(11)230405, (01)00840682116862(21)TABC70341(11)230406, (01)00840682116862(21)TABC70342(11)230406, (01)00840682116862(21)TABC70343(11)230406, (01)00840682116862(21)TABC70344(11)230406, (01)00840682116862(21)TABC70350(11)230410, (01)00840682116862(21)TABC70351(11)230410, (01)00840682116862(21)TABC70352(11)230411, (01)00840682116862(21)TABC70106(11)230215, (01)00840682116862(21)TABC70125(11)230220, (01)00840682116862(21)TABC70141(11)230222, (01)00840682116862(21)TABC70147(11)230223, (01)00840682116862(21)TABC70148(11)230224, (01)00840682116862(21)TABC70160(11)230227, (01)00840682116862(21)TABC70161(11)230227, (01)00840682116862(21)TABC70165(11)230228, (01)00840682116862(21)TABC70175(11)230301, (01)00840682116862(21)TABC70182(11)230302;
11) 2082844-001-01090414, UDI: (01)008406821168622(21)TAB23110035SA(11)230316, (01)008406821168622(21)TAB23110036SA(11)230316, (01)008406821168622(21)TAB23110037SA(11)230316, (01)008406821168622(21)TAB23110038SA(11)230316, (01)008406821168622(21)TAB23110039SA(11)230316, (01)008406821168622(21)TAB23110040SA(11)230316, (01)008406821168622(21)TAB23110041SA(11)230316;
12) 2082844-001-01092632, UDI: (01)00840682116862(21)TABC70082(11)230214,
(01)00840682116862(21)TABC70089(11)230214;
13) 2082844-001-01111482, UDI: (01)008406821168622(21)TAB23060016SA(11)230209, (01)008406821168622(21)TAB23060017SA(11)230209, (01)008406821168622(21)TAB23060018SA(11)230209, (01)008406821168622(21)TAB23060019SA(11)230209, (01)008406821168622(21)TAB23060020SA(11)230209, (01)008406821168622(21)TAB23060021SA(11)230209, (01)008406821168622(21)TAB23060022SA(11)230209, (01)008406821168622(21)TAB23060023SA(11)230209, (01)008406821168622(21)TAB23060032SA(11)230210, (01)008406821168622(21)TAB23060033SA(11)230210, (01)008406821168622(21)TAB23060034SA(11)230210;
14) 2082844-001-01115741, UDI: (01)008406821168622(21)TAB23120056SA(11)230325;
15) 2082844-001-01122391, UDI: (01)00840682116862(21)TABC70164(11)230228;
16) 2082844-001-01128579, UDI: (01)00840682116862(21)TABC70287(11)230320, (01)00840682116862(21)TABC70288(11)230320, (01)00840682116862(21)TABC70291(11)230320, (01)00840682116862(21)TABC70294(11)230322, (01)00840682116862(21)TABC70295(11)230322, (01)00840682116862(21)TABC70296(11)230322, (01)00840682116862(21)TABC70300(11)230323, (01)00840682116862(21)TABC70301(11)230323;
17) 2082844-001-01128725, UDI: (01)008406821168622(21)TAB23150008SA(11)230411,
(01)008406821168622(21)TAB23150009SA(11)230411;
18) 2082844-001-01131573, UDI: (01)008406821168622(21)TAB23190004SA(11)230508;
19) 2082844-001-01140642, UDI: (01)008406821168622(21)TAB23140038SA(11)230404;
20) 2082844-001-01165870, UDI: (01)00840682116862(21)TABC70111(11)230216;
21) 2082844-001-100397, UDI: (01)008406821168622(21)TAB23130005SA(11)230327, (01)008406821168622(21)TAB23130012SA(11)230328, (01)008406821168622(21)TAB23130013SA(11)230328, (01)008406821168622(21)TAB23130014SA(11)230328, (01)008406821168622(21)TAB23130015SA(11)230328;
22) 2082844-001-100676, UDI: (01)008406821168622(21)TAB23140034SA(11)230404, (01)008406821168622(21)TAB23140037SA(11)230404, (01)008406821168622(21)TAB23150001SA(11)230411, (01)008406821168622(21)TAB23090054SA(11)230304, (01)008406821168622(21)TAB23090055SA(11)230304, (01)008406821168622(21)TAB23090057SA(11)230304;
23) 2082844-001-100740, UDI: (01)008406821168622(21)TAB23090058SA(11)230304, (01)008406821168622(21)TAB23090059SA(11)230304, (01)008406821168622(21)TAB23170015SA(11)230425;
24) 2082844-001-100743, UDI: (01)008406821168622(21)TAB23110025SA(11)230315;
25) 2082844-001-100744, UDI: (01)008406821168622(21)TAB23120008SA(11)230321, (01)008406821168622(21)TAB23120009SA(11)230321, (01)008406821168622(21)TAB23110026SA(11)230315, (01)00840682116862(21)TABC70152(11)230224, (01)00840682116862(21)TABC70153(11)230224, (01)00840682116862(21)TABC70154(11)230224, (01)008406821168622(21)TAB23110001SA(11)230313, (01)008406821168622(21)TAB23110002SA(11)230313, (01)008406821168622(21)TAB23110003SA(11)230313, (01)008406821168622(21)TAB23110004SA(11)230313, (01)008406821168622(21)TAB23110005SA(11)230313, (01)008406821168622(21)TAB23110006SA(11)230313, (01)008406821168622(21)TAB23110007SA(11)230313, (01)008406821168622(21)TAB23110008SA(11)230313, (01)008406821168622(21)TAB23100021SA(11)230308, (01)008406821168622(21)TAB23100022SA(11)230309, (01)008406821168622(21)TAB23100023SA(11)230309, (01)008406821168622(21)TAB23100024SA(11)230309, (01)008406821168622(21)TAB23100025SA(11)230309, (01)008406821168622(21)TAB23100026SA(11)230309, (01)008406821168622(21)TAB23100027SA(11)230309, (01)008406821168622(21)TAB23100028SA(11)230309, (01)008406821168622(21)TAB23100029SA(11)230309, (01)008406821168622(21)TAB23100030SA(11)230309, (01)008406821168622(21)TAB23190038SA(11)230511, (01)008406821168622(21)TAB23190039SA(11)230511, (01)008406821168622(21)TAB23190040SA(11)230511, (01)00840682116862(21)TABC70373(11)230412, (01)008406821168622(21)TAB23150021SA(11)230412, (01)008406821168622(21)TAB23160021SA(11)230418, (01)008406821168622(21)TAB23160022SA(11)230418, (01)008406821168622(21)TAB23160023SA(11)230418, (01)008406821168622(21)TAB23160025SA(11)230418, (01)008406821168622(21)TAB23190032SA(11)230510, (01)008406821168622(21)TAB23180061SA(11)230506, (01)008406821168622(21)TAB23180062SA(11)230506, (01)008406821168622(21)TAB23180063SA(11)230506, (01)008406821168622(21)TAB23110044SA(11)230317, (01)008406821168622(21)TAB23110048SA(11)230317, (01)008406821168622(21)TAB23110049SA(11)230317, (01)008406821168622(21)TAB23110051SA(11)230317, (01)008406821168622(21)TAB23110052SA(11)230317, (01)008406821168622(21)TAB23110053SA(11)230317, (01)008406821168622(21)TAB23110054SA(11)230317, (01)008406821168622(21)TAB23120001SA(11)230320, (01)008406821168622(21)TAB23120002SA(11)230320, (01)008406821168622(21)TAB23120003SA(11)230320, (01)008406821168622(21)TAB23120004SA(11)230320, (01)008406821168622(21)TAB23120005SA(11)230321, (01)008406821168622(21)TAB23120006SA(11)230321, (01)008406821168622(21)TAB23120007SA(11)230321, (01)00840682116862(21)TABC70208(11)230307, (01)00840682116862(21)TABC70226(11)230309, (01)00840682116862(21)TABC70234(11)230310, (01)00840682116862(21)TABC70243(11)230313, (01)00840682116862(21)TABC70253(11)230314, (01)00840682116862(21)TABC70259(11)230315, (01)00840682116862(21)TABC70261(11)230315, (01)00840682116862(21)TABC70262(11)230315, (01)00840682116862(21)TABC70263(11)230315, (01)00840682116862(21)TABC70239(11)230313, (01)008406821168622(21)TAB23110009SA(11)230313, (01)008406821168622(21)TAB23110010SA(11)230313, (01)008406821168622(21)TAB23110011SA(11)230313, (01)008406821168622(21)TAB23110012SA(11)230314, (01)008406821168622(21)TAB23110013SA(11)230314, (01)008406821168622(21)TAB23110014SA(11)230314, (01)00840682116862(21)TABC70265(11)230315, (01)00840682116862(21)TABC70371(11)230412, (01)00840682116862(21)TABC70372(11)230412, (01)008406821168622(21)TAB23190041SA(11)230511, (01)008406821168622(21)TAB23190046SA(11)230511, (01)008406821168622(21)TAB23190047SA(11)230511, (01)008406821168622(21)TAB23190048SA(11)230511, (01)008406821168622(21)TAB23190050SA(11)230511, (01)008406821168622(21)TAB23110027SA(11)230315, (01)008406821168622(21)TAB23110029SA(11)230315, (01)008406821168622(21)TAB23110032SA(11)230315, (01)008406821168622(21)TAB23190042SA(11)230511, (01)008406821168622(21)TAB23190043SA(11)230511, (01)008406821168622(21)TAB23190044SA(11)230511, (01)008406821168622(21)TAB23190045SA(11)230511, (01)008406821168622(21)TAB23190049SA(11)230511, (01)008406821168622(21)TAB23120035SA(11)230323, (01)008406821168622(21)TAB23190030SA(11)230510, (01)008406821168622(21)TAB23190031SA(11)230510, (01)00840682116862(21)TABC70219(11)230308, (01)00840682116862(21)TABC70241(11)230313, (01)008406821168622(21)TAB23170026SA(11)230426, (01)008406821168622(21)TAB23170027SA(11)230426, (01)008406821168622(21)TAB23170028SA(11)230426, (01)008406821168622(21)TAB23170029SA(11)230426, (01)008406821168622(21)TAB23170032SA(11)230426, (01)008406821168622(21)TAB23170030SA(11)230426, (01)008406821168622(21)TAB23170031SA(11)230426, (01)008406821168622(21)TAB23170033SA(11)230426, (01)008406821168622(21)TAB23170034SA(11)230426, (01)008406821168622(21)TAB23180001SA(11)230503, (01)008406821168622(21)TAB23180002SA(11)230503, (01)008406821168622(21)TAB23180003SA(11)230503, (01)008406821168622(21)TAB23180004SA(11)230503, (01)008406821168622(21)TAB23180005SA(11)230503, (01)008406821168622(21)TAB23180006SA(11)230503, (01)008406821168622(21)TAB23180007SA(11)230503, (01)008406821168622(21)TAB23180008SA(11)230503, (01)008406821168622(21)TAB23180009SA(11)230503, (01)008406821168622(21)TAB23180010SA(11)230503, (01)008406821168622(21)TAB23180011SA(11)230503, (01)008406821168622(21)TAB23100033SA(11)230310, (01)008406821168622(21)TAB23100031SA(11)230310, (01)008406821168622(21)TAB23190014SA(11)230509, (01)008406821168622(21)TAB23190017SA(11)230509, (01)008406821168622(21)TAB23190018SA(11)230509, (01)008406821168622(21)TAB23190019SA(11)230509, (01)00840682116862(21)TABC70206(11)230307, (01)00840682116862(21)TABC70207(11)230307, (01)00840682116862(21)TABC70218(11)230308, (01)00840682116862(21)TABC70231(11)230309, (01)00840682116862(21)TABC70247(11)230313, (01)00840682116862(21)TABC70256(11)230314, (01)008406821168622(21)TAB23190008SA(11)230509, (01)008406821168622(21)TAB23100010SA(11)230306, (01)008406821168622(21)TAB23120017SA(11)230322, (01)00840682116862(21)TABC70238(11)230310, (01)00840682116862(21)TABC70248(11)230313, (01)008406821168622(21)TAB23120031SA(11)230323, (01)008406821168622(21)TAB23100017SA(11)230308, (01)008406821168622(21)TAB23100018SA(11)230308, (01)008406821168622(21)TAB23100019SA(11)230308, (01)008406821168622(21)TAB23100020SA(11)230308, (01)008406821168622(21)TAB23170018SA(11)230426, (01)008406821168622(21)TAB23170019SA(11)230426, (01)008406821168622(21)TAB23170020SA(11)230426, (01)008406821168622(21)TAB23170021SA(11)230426, (01)008406821168622(21)TAB23170022SA(11)230426, (01)008406821168622(21)TAB23170023SA(11)230426, (01)008406821168622(21)TAB23180041SA(11)230504, (01)008406821168622(21)TAB23180042SA(11)230504, (01)008406821168622(21)TAB23180043SA(11)230504, (01)008406821168622(21)TAB23180044SA(11)230504, (01)008406821168622(21)TAB23180045SA(11)230504, (01)008406821168622(21)TAB23180046SA(11)230504, (01)008406821168622(21)TAB23180047SA(11)230504, (01)008406821168622(21)TAB23180048SA(11)230504, (01)008406821168622(21)TAB23180049SA(11)230504, (01)008406821168622(21)TAB23180050SA(11)230504, (01)008406821168622(21)TAB23180051SA(11)230504, (01)008406821168622(21)TAB23180052SA(11)230504, (01)008406821168622(21)TAB23180053SA(11)230504, (01)008406821168622(21)TAB23180054SA(11)230504, (01)008406821168622(21)TAB23180055SA(11)230504, (01)008406821168622(21)TAB23180056SA(11)230504, (01)008406821168622(21)TAB23180057SA(11)230504, (01)008406821168622(21)TAB23180058SA(11)230504, (01)008406821168622(21)TAB23180059SA(11)230504, (01)008406821168622(21)TAB23180060SA(11)230504, (01)008406821168622(21)TAB23090060SA(11)230304, (01)008406821168622(21)TAB23090061SA(11)230304, (01)008406821168622(21)TAB23090062SA(11)230304, (01)008406821168622(21)TAB23090063SA(11)230304, (01)008406821168622(21)TAB23090064SA(11)230304, (01)008406821168622(21)TAB23090065SA(11)230304, (01)008406821168622(21)TAB23090066SA(11)230304, (01)008406821168622(21)TAB23090067SA(11)230304, (01)008406821168622(21)TAB23090068SA(11)230304, (01)008406821168622(21)TAB23110022SA(11)230315, (01)008406821168622(21)TAB23110023SA(11)230315, (01)008406821168622(21)TAB23110042SA(11)230316, (01)008406821168622(21)TAB23120028SA(11)230323, (01)008406821168622(21)TAB23120029SA(11)230323, (01)008406821168622(21)TAB23120030SA(11)230323, (01)008406821168622(21)TAB23120033SA(11)230323, (01)00840682116862(21)TABC70254(11)230314, (01)008406821168622(21)TAB23120025SA(11)230323, (01)008406821168622(21)TAB23120034SA(11)230323, (01)008406821168622(21)TAB23120036SA(11)230324, (01)008406821168622(21)TAB23120037SA(11)230324, (01)008406821168622(21)TAB23120043SA(11)230324, (01)008406821168622(21)TAB23120044SA(11)230324, (01)008406821168622(21)TAB23120045SA(11)230324, (01)008406821168622(21)TAB23120046SA(11)230324, (01)008406821168622(21)TAB23120049SA(11)230325, (01)008406821168622(21)TAB23120050SA(11)230325, (01)008406821168622(21)TAB23120052SA(11)230325, (01)008406821168622(21)TAB23120055SA(11)230325, (01)008406821168622(21)TAB23120053SA(11)230325, (01)008406821168622(21)TAB23110034SA(11)230315, (01)008406821168622(21)TAB23110045SA(11)230317, (01)008406821168622(21)TAB23110046SA(11)230317, (01)008406821168622(21)TAB23110047SA(11)230317, (01)008406821168622(21)TAB23110050SA(11)230317, (01)008406821168622(21)TAB23110016SA(11)230314, (01)008406821168622(21)TAB23110017SA(11)230314, (01)008406821168622(21)TAB23110018SA(11)230314, (01)008406821168622(21)TAB23110019SA(11)230314, (01)008406821168622(21)TAB23110021SA(11)230314, (01)008406821168622(21)TAB23110024SA(11)230315, (01)008406821168622(21)TAB23120015SA(11)230322, (01)008406821168622(21)TAB23120016SA(11)230322, (01)008406821168622(21)TAB23120018SA(11)230322, (01)008406821168622(21)TAB23120020SA(11)230322, (01)008406821168622(21)TAB23120022SA(11)230323, (01)008406821168622(21)TAB23120026SA(11)230323, (01)008406821168622(21)TAB23110028SA(11)230315, (01)008406821168622(21)TAB23110030SA(11)230315, (01)008406821168622(21)TAB23110031SA(11)230315, (01)008406821168622(21)TAB23110033SA(11)230315, (01)008406821168622(21)TAB23190035SA(11)230510, (01)008406821168622(21)TAB23190036SA(11)230510, (01)008406821168622(21)TAB23190037SA(11)230510, (01)008406821168622(21)TAB23180066SA(11)230506, (01)008406821168622(21)TAB23180067SA(11)230506, (01)008406821168622(21)TAB23180068SA(11)230506, (01)008406821168622(21)TAB23180069SA(11)230506, (01)008406821168622(21)TAB23190012SA(11)230509, (01)008406821168622(21)TAB23190013SA(11)230509, (01)008406821168622(21)TAB23190015SA(11)230509, (01)008406821168622(21)TAB23190016SA(11)230509, (01)008406821168622(21)TAB23110043SA(11)230317, (01)008406821168622(21)TAB23120011SA(11)230322, (01)008406821168622(21)TAB23120012SA(11)230322, (01)008406821168622(21)TAB23120013SA(11)230322, (01)008406821168622(21)TAB23120014SA(11)230322, (01)008406821168622(21)TAB23120038SA(11)230324, (01)008406821168622(21)TAB23120039SA(11)230324, (01)008406821168622(21)TAB23120040SA(11)230324, (01)008406821168622(21)TAB23120041SA(11)230324, (01)008406821168622(21)TAB23180064SA(11)230506, (01)008406821168622(21)TAB23180065SA(11)230506, (01)00840682116862(21)TABC70204(11)230307, (01)00840682116862(21)TABC70216(11)230308, (01)00840682116862(21)TABC70217(11)230308, (01)00840682116862(21)TABC70223(11)230309, (01)00840682116862(21)TABC70224(11)230309, (01)008406821168622(21)TAB23110020SA(11)230314, (01)008406821168622(21)TAB23120010SA(11)230322, (01)008406821168622(21)TAB23120019SA(11)230322, (01)008406821168622(21)TAB23120021SA(11)230322, (01)008406821168622(21)TAB23120042SA(11)230324, (01)008406821168622(21)TAB23120047SA(11)230325, (01)008406821168622(21)TAB23100005SA(11)230306, (01)008406821168622(21)TAB23100006SA(11)230306, (01)008406821168622(21)TAB23100007SA(11)230306, (01)008406821168622(21)TAB23100008SA(11)230306, (01)008406821168622(21)TAB23100009SA(11)230306, (01)008406821168622(21)TAB23100011SA(11)230306, (01)008406821168622(21)TAB23120048SA(11)230325, (01)008406821168622(21)TAB23120051SA(11)230325, (01)008406821168622(21)TAB23120054SA(11)230325, (01)008406821168622(21)TAB23150020SA(11)230412, (01)008406821168622(21)TAB23150036SA(11)230412, (01)008406821168622(21)TAB23150022SA(11)230412, (01)008406821168622(21)TAB23150023SA(11)230412, (01)008406821168622(21)TAB23150024SA(11)230412, (01)008406821168622(21)TAB23150025SA(11)230412, (01)008406821168622(21)TAB23150026SA(11)230412, (01)008406821168622(21)TAB23150027SA(11)230412, (01)008406821168622(21)TAB23150028SA(11)230412, (01)008406821168622(21)TAB23150029SA(11)230412, (01)008406821168622(21)TAB23150030SA(11)230412, (01)008406821168622(21)TAB23150031SA(11)230412, (01)008406821168622(21)TAB23150032SA(11)230412, (01)008406821168622(21)TAB23150033SA(11)230412, (01)008406821168622(21)TAB23150034SA(11)230412, (01)008406821168622(21)TAB23150035SA(11)230412, (01)008406821168622(21)TAB23150037SA(11)230412, (01)008406821168622(21)TAB23150038SA(11)230412, (01)008406821168622(21)TAB23150039SA(11)230412, (01)008406821168622(21)TAB23150040SA(11)230412, (01)008406821168622(21)TAB23160004SA(11)230417, (01)008406821168622(21)TAB23160006SA(11)230417, (01)008406821168622(21)TAB23150041SA(11)230412, (01)008406821168622(21)TAB23160001SA(11)230417, (01)008406821168622(21)TAB23160002SA(11)230417, (01)008406821168622(21)TAB23160003SA(11)230417, (01)008406821168622(21)TAB23160005SA(11)230417, (01)008406821168622(21)TAB23160007SA(11)230417, (01)008406821168622(21)TAB23160008SA(11)230417, (01)008406821168622(21)TAB23160009SA(11)230417, (01)008406821168622(21)TAB23160010SA(11)230417, (01)008406821168622(21)TAB23160011SA(11)230417, (01)008406821168622(21)TAB23160012SA(11)230417, (01)008406821168622(21)TAB23160013SA(11)230417, (01)008406821168622(21)TAB23160014SA(11)230417, (01)008406821168622(21)TAB23160015SA(11)230417, (01)008406821168622(21)TAB23160016SA(11)230417, (01)008406821168622(21)TAB23160017SA(11)230417, (01)008406821168622(21)TAB23160018SA(11)230417, (01)008406821168622(21)TAB23160019SA(11)230417, (01)008406821168622(21)TAB23160020SA(11)230417, (01)008406821168622(21)TAB23160024SA(11)230418, (01)008406821168622(21)TAB23100012SA(11)230306, (01)008406821168622(21)TAB23100013SA(11)230307, (01)008406821168622(21)TAB23100014SA(11)230307, (01)008406821168622(21)TAB23100015SA(11)230307, (01)008406821168622(21)TAB23120027SA(11)230323, (01)008406821168622(21)TAB23120032SA(11)230323, (01)008406821168622(21)TAB23100034SA(11)230310, (01)008406821168622(21)TAB23120023SA(11)230323, (01)008406821168622(21)TAB23120024SA(11)230323, (01)008406821168622(21)TAB23190051SA(11)230513, (01)008406821168622(21)TAB23200019SA(11)230517, (01)00840682116862(21)TABC70227(11)230309, (01)00840682116862(21)TABC70228(11)230309, (01)00840682116862(21)TABC70229(11)230309, (01)00840682116862(21)TABC70250(11)230314, (01)00840682116862(21)TABC70260(11)230315, (01)008406821168622(21)TAB23110015SA(11)230314;
26) 2082844-001-101075, UDI: (01)00840682116862(21)TABC70051(11)230208, (01)00840682116862(21)TABC70062(11)230209, (01)00840682116862(21)TABC70072(11)230210, (01)00840682116862(21)TABC70083(11)230214, (01)00840682116862(21)TABC70091(11)230214, (01)00840682116862(21)TABC70098(11)230215, (01)00840682116862(21)TABC70099(11)230215, (01)00840682116862(21)TABC70102(11)230215;
27) 2082844-001-101149, UDI: (01)00840682116862(21)TABC70012(11)230201, (01)00840682116862(21)TABC70014(11)230202, (01)00840682116862(21)TABC70015(11)230202, (01)00840682116862(21)TABC70020(11)230203, (01)00840682116862(21)TABC70021(11)230203, (01)00840682116862(21)TABC70023(11)230203, (01)00840682116862(21)TABC70026(11)230203;
28) 2082844-001-101199, UDI: (01)00840682116862(21)TABC70140(11)230222, (01)00840682116862(21)TABC70150(11)230224, (01)00840682116862(21)TABC70186(11)230303, (01)00840682116862(21)TABC70283(11)230317, (01)00840682116862(21)TABC70302(11)230323, (01)00840682116862(21)TABC70304(11)230323, (01)00840682116862(21)TABC70305(11)230323, (01)00840682116862(21)TABC70311(11)230324, (01)00840682116862(21)TABC70312(11)230327, (01)00840682116862(21)TABC70315(11)230327, (01)00840682116862(21)TABC70322(11)230329, (01)00840682116862(21)TABC70330(11)230330;
29) 2082844-001-101202, UDI: (01)008406821168622(21)TAB23120057SA(11)230325;
30) 2082844-001-101203, UDI: (01)008406821168622(21)TAB23150005SA(11)230411, (01)008406821168622(21)TAB23150006SA(11)230411, (01)008406821168622(21)TAB23150010SA(11)230412, (01)008406821168622(21)TAB23150011SA(11)230412, (01)008406821168622(21)TAB23150013SA(11)230412, (01)008406821168622(21)TAB23150015SA(11)230412, (01)008406821168622(21)TAB23150016SA(11)230412, (01)008406821168622(21)TAB23150017SA(11)230412, (01)008406821168622(21)TAB23150018SA(11)230412, (01)008406821168622(21)TAB23150019SA(11)230412;
31) 2082844-001-101356, UDI: (01)008406821168622(21)TAB23170005SA(11)230425;
32) 2082844-001-101366, UDI: (01)008406821168622(21)TAB23090045SA(11)230302, (01)008406821168622(21)TAB23090046SA(11)230302, (01)008406821168622(21)TAB23090047SA(11)230302;
33) 2082844-001-101656, UDI: (01)00840682116862(21)TABC70027(11)230203, (01)00840682116862(21)TABC70036(11)230207, (01)00840682116862(21)TABC70040(11)230208;
34) 2082844-001-102136, UDI: (01)008406821168622(21)TAB23190024SA(11)230510, (01)008406821168622(21)TAB23190025SA(11)230510, (01)008406821168622(21)TAB23190026SA(11)230510, (01)008406821168622(21)TAB23190027SA(11)230510, (01)008406821168622(21)TAB23190028SA(11)230510, (01)008406821168622(21)TAB23190029SA(11)230510, (01)008406821168622(21)TAB23190009SA(11)230509, (01)008406821168622(21)TAB23190010SA(11)230509, (01)008406821168622(21)TAB23190011SA(11)230509, (01)008406821168622(21)TAB23100032SA(11)230310;
35) 2082844-001-102589, UDI: (01)00840682116862(21)TABC70268(11)230315;
36) 2082844-001-102858, UDI: (01)008406821168622(21)TAB23140023SA(11)230404, (01)008406821168622(21)TAB23140024SA(11)230404, (01)008406821168622(21)TAB23140025SA(11)230404, (01)008406821168622(21)TAB23140026SA(11)230404, (01)008406821168622(21)TAB23140027SA(11)230404;
37) 2082844-001-526493, UDI: (01)008406821168622(21)TAB23140001SA(11)230403, (01)008406821168622(21)TAB23140002SA(11)230403, (01)008406821168622(21)TAB23140003SA(11)230403, (01)008406821168622(21)TAB23140004SA(11)230403, (01)008406821168622(21)TAB23140005SA(11)230403, (01)008406821168622(21)TAB23140006SA(11)230403, (01)008406821168622(21)TAB23140007SA(11)230403, (01)008406821168622(21)TAB23140008SA(11)230403, (01)008406821168622(21)TAB23140009SA(11)230403, (01)008406821168622(21)TAB23140010SA(11)230403, (01)008406821168622(21)TAB23140011SA(11)230403, (01)008406821168622(21)TAB23140012SA(11)230403, (01)008406821168622(21)TAB23140013SA(11)230403, (01)008406821168622(21)TAB23140014SA(11)230403, (01)008406821168622(21)TAB23140015SA(11)230403, (01)008406821168622(21)TAB23140016SA(11)230403, (01)008406821168622(21)TAB23140017SA(11)230403, (01)008406821168622(21)TAB23140018SA(11)230403, (01)008406821168622(21)TAB23140019SA(11)230403, (01)008406821168622(21)TAB23140020SA(11)230403, (01)008406821168622(21)TAB23140022SA(11)230404, (01)00840682116862(21)TABB71903(11)221221, (01)00840682116862(21)TABC70225(11)230309, (01)00840682116862(21)TABC70236(11)230310, (01)00840682116862(21)TABC70251(11)230314, (01)00840682116862(21)TABC70267(11)230315, (01)00840682116862(21)TABC70290(11)230320, (01)00840682116862(21)TABC70203(11)230307, (01)00840682116862(21)TABC70205(11)230307, (01)00840682116862(21)TABC70209(11)230307, (01)00840682116862(21)TABC70213(11)230307, (01)00840682116862(21)TABC70214(11)230307, (01)00840682116862(21)TABC70215(11)230308, (01)00840682116862(21)TABC70222(11)230309, (01)00840682116862(21)TABC70230(11)230309, (01)00840682116862(21)TABC70232(11)230309, (01)00840682116862(21)TABC70233(11)230310, (01)00840682116862(21)TABC70235(11)230310, (01)00840682116862(21)TABC70237(11)230310, (01)00840682116862(21)TABC70240(11)230313, (01)00840682116862(21)TABC70242(11)230313, (01)00840682116862(21)TABC70244(11)230313, (01)00840682116862(21)TABC70245(11)230313, (01)00840682116862(21)TABC70246(11)230313, (01)00840682116862(21)TABC70249(11)230313, (01)00840682116862(21)TABC70252(11)230314, (01)00840682116862(21)TABC70255(11)230314, (01)00840682116862(21)TABC70257(11)230314, (01)00840682116862(21)TABC70258(11)230315;
38) 2082844-001-533346, UDI: (01)008406821168622(21)TAB23160042SA(11)230421, (01)008406821168622(21)TAB23160043SA(11)230421, (01)008406821168622(21)TAB23160044SA(11)230421, (01)008406821168622(21)TAB23160045SA(11)230421, (01)008406821168622(21)TAB23160046SA(11)230421, (01)008406821168622(21)TAB23160047SA(11)230421, (01)008406821168622(21)TAB23160048SA(11)230421, (01)008406821168622(21)TAB23160049SA(11)230421, (01)008406821168622(21)TAB23160050SA(11)230421, (01)008406821168622(21)TAB23160051SA(11)230421, (01)008406821168622(21)TAB23160052SA(11)230421, (01)008406821168622(21)TAB23160053SA(11)230421, (01)008406821168622(21)TAB23160054SA(11)230421, (01)008406821168622(21)TAB23160055SA(11)230421;
39) 2082844-001-570904, UDI: (01)00840682116862(21)TABC70096(11)230215, (01)00840682116862(21)TABC70107(11)230215, (01)00840682116862(21)TABC70113(11)230216, (01)00840682116862(21)TABC70156(11)230227, (01)00840682116862(21)TABC70281(11)230317, (01)00840682116862(21)TABC70282(11)230317, (01)00840682116862(21)TABC70284(11)230317, (01)00840682116862(21)TABC70306(11)230323, (01)00840682116862(21)TABC70046(11)230208, (01)00840682116862(21)TABC70055(11)230209, (01)00840682116862(21)TABC70059(11)230209, (01)00840682116862(21)TABC70079(11)230213, (01)00840682116862(21)TABC70088(11)230214, (01)00840682116862(21)TABC70090(11)230214, (01)00840682116862(21)TABC70095(11)230215, (01)00840682116862(21)TABC70097(11)230215, (01)00840682116862(21)TABC70105(11)230215, (01)00840682116862(21)TABC70114(11)230216, (01)00840682116862(21)TABC70124(11)230217, (01)00840682116862(21)TABC70132(11)230221;
40) 2082844-001-615985, UDI: (01)008406821168622(21)TAB23120058SA(11)230325;
41) 2082844-001-616544, UDI: (01)00840682116862(21)TABC70212(11)230307;
42) 2082844-001-674814, UDI: (01)00840682116862(21)TABC70167(11)230228, (01)00840682116862(21)TABC70193(11)230303, (01)00840682116862(21)TABC70194(11)230306, (01)00840682116862(21)TABC70210(11)230307, (01)00840682116862(21)TABC70211(11)230307, (01)00840682116862(21)TABC70220(11)230308;
43) 2082844-001-701655, UDI: (01)008406821168622(21)TAB23180032SA(11)230504, (01)008406821168622(21)TAB23180033SA(11)230504, (01)008406821168622(21)TAB23180034SA(11)230504, (01)008406821168622(21)TAB23180035SA(11)230504, (01)008406821168622(21)TAB23180036SA(11)230504, (01)008406821168622(21)TAB23180037SA(11)230504, (01)008406821168622(21)TAB23180038SA(11)230504, (01)008406821168622(21)TAB23180039SA(11)230504, (01)008406821168622(21)TAB23180040SA(11)230504, (01)008406821168622(21)TAB23070034SA(11)230215, (01)008406821168622(21)TAB23070035SA(11)230215, (01)008406821168622(21)TAB23070036SA(11)230215, (01)008406821168622(21)TAB23070037SA(11)230215, (01)008406821168622(21)TAB23070038SA(11)230215, (01)008406821168622(21)TAB23070039SA(11)230215, (01)008406821168622(21)TAB23070040SA(11)230215, (01)008406821168622(21)TAB23070041SA(11)230215, (01)008406821168622(21)TAB23060001SA(11)230208;
44) 2082844-001-704407, UDI: (01)008406821168622(21)TAB23050001SA(11)230131, (01)008406821168622(21)TAB23050002SA(11)230131, (01)008406821168622(21)TAB23050003SA(11)230131, (01)008406821168622(21)TAB23050004SA(11)230131, (01)008406821168622(21)TAB23050005SA(11)230131, (01)008406821168622(21)TAB23050007SA(11)230131, (01)008406821168622(21)TAB23050008SA(11)230131, (01)008406821168622(21)TAB23050010SA(11)230131, (01)008406821168622(21)TAB23050011SA(11)230131, (01)008406821168622(21)TAB23050012SA(11)230131, (01)00840682116862(21)TABB70418(11)220406, (01)00840682116862(21)TABB71582(11)221011, (01)008406821168622(21)TAB23090015SA(11)230228, (01)008406821168622(21)TAB23090016SA(11)230228, (01)008406821168622(21)TAB23090017SA(11)230228, (01)008406821168622(21)TAB23090018SA(11)230228, (01)008406821168622(21)TAB23090020SA(11)230228;
45) 2082844-001-709042, UDI: (01)00840682116862(21)TABC70292(11)230320;
46) 2082844-001-857748, UDI: (01)008406821168622(21)TAB23170004SA(11)230425, (01)008406821168622(21)TAB23130008SA(11)230327, (01)008406821168622(21)TAB23130009SA(11)230327;
47) 2082844-001-888278, UDI: (01)008406821168622(21)TAB23200004SA(11)230516, (01)008406821168622(21)TAB23200005SA(11)230516, (01)008406821168622(21)TAB23200006SA(11)230516, (01)008406821168622(21)TAB23200007SA(11)230516, (01)008406821168622(21)TAB23200008SA(11)230516, (01)008406821168622(21)TAB23200009SA(11)230516;
48) 2082844-001-941288, UDI: (01)00840682116862(21)TABC70149(11)230224, (01)00840682116862(21)TABC70168(11)230228, (01)00840682116862(21)TABC70176(11)230301, (01)00840682116862(21)TABC70184(11)230303, (01)00840682116862(21)TABC70201(11)230306;
49) 2082844-001-965539, UDI: (01)00840682116862(21)TABC70318(11)230328, (01)00840682116862(21)TABC70324(11)230329;
50) 2082844-001-978713, UDI: (01)00840682116862(21)TABC70188(11)230303;
51) 2082844-001-982099, UDI: (01)00840682116862(21)TABC70142(11)230222, (01)00840682116862(21)TABC70177(11)230301, (01)00840682116862(21)TABC70191(11)230303, (01)00840682116862(21)TABC70200(11)230306, (01)00840682116862(21)TABC70202(11)230307, (01)00840682116862(21)TABC70115(11)230216, (01)00840682116862(21)TABC70131(11)230221, (01)00840682116862(21)TABC70159(11)230227, (01)00840682116862(21)TABC70174(11)230301, (01)00840682116862(21)TABC70192(11)230303, (01)00840682116862(21)TABC70199(11)230306;
52) 2082844-001-982310, UDI: (01)00840682116862(21)TABC70110(11)230216, (01)00840682116862(21)TABC70112(11)230216, (01)00840682116862(21)TABC70118(11)230217, (01)00840682116862(21)TABC70122(11)230217, (01)00840682116862(21)TABC70123(11)230217, (01)00840682116862(21)TABC70135(11)230221, (01)00840682116862(21)TABC70145(11)230223, (01)00840682116862(21)TABC70151(11)230224, (01)00840682116862(21)TABC70155(11)230227, (01)00840682116862(21)TABC70157(11)230227, (01)00840682116862(21)TABC70277(11)230316, (01)00840682116862(21)TABC70334(11)230403, (01)00840682116862(21)TABC70340(11)230405, (01)00840682116862(21)TABC70347(11)230406, (01)00840682116862(21)TABC70313(11)230327, (01)00840682116862(21)TABC70120(11)230217, (01)00840682116862(21)TABC70317(11)230328, (01)00840682116862(21)TABC70319(11)230328;
53) 2082844-001-982985, UDI: (01)008406821168622(21)TAB23150002SA(11)230411, (01)008406821168622(21)TAB23140039SA(11)230404, (01)008406821168622(21)TAB23150003SA(11)230411, (01)008406821168622(21)TAB23150004SA(11)230411, (01)008406821168622(21)TAB23150007SA(11)230411, (01)008406821168622(21)TAB23150012SA(11)230412, (01)008406821168622(21)TAB23150014SA(11)230412;
54) 2082844-001-982988, UDI: (01)008406821168622(21)TAB23130006SA(11)230327, (01)008406821168622(21)TAB23130007SA(11)230327;
55) 2082844-001-983509, UDI: (01)00840682116862(21)TABC70221(11)230309;
56) 2082844-001-983643, UDI: (01)008406821168622(21)TAB23050016SA(11)230131;
57) 2082844-001-983679, UDI: (01)008406821168622(21)TAB23170046SA(11)230427;
58) 2082844-001-984096, UDI: (01)008406821168622(21)TAB23090012SA(11)230227, (01)008406821168622(21)TAB23120059SA(11)230325, (01)008406821168622(21)TAB23120060SA(11)230325, (01)008406821168622(21)TAB23130016SA(11)230328, (01)008406821168622(21)TAB23130017SA(11)230328, (01)008406821168622(21)TAB23130018SA(11)230328, (01)008406821168622(21)TAB23130019SA(11)230328, (01)008406821168622(21)TAB23130020SA(11)230328, (01)008406821168622(21)TAB23170024SA(11)230426, (01)008406821168622(21)TAB23170025SA(11)230426, (01)008406821168622(21)TAB23080066SA(11)230224;
59) 2082844-001-984948, UDI: (01)008406821168622(21)TAB23090013SA(11)230227, (01)008406821168622(21)TAB23190006SA(11)230508, (01)008406821168622(21)TAB23190007SA(11)230508, (01)008406821168622(21)TAB23190005SA(11)230508, (01)008406821168622(21)TAB23190003SA(11)230508, (01)008406821168622(21)TAB23020024SA(11)230110, (01)008406821168622(21)TAB23020025SA(11)230110, (01)008406821168622(21)TAB23020014SA(11)230110, (01)008406821168622(21)TAB23090001SA(11)230227, (01)008406821168622(21)TAB23190020SA(11)230509, (01)008406821168622(21)TAB23190021SA(11)230509, (01)008406821168622(21)TAB23190022SA(11)230509, (01)008406821168622(21)TAB23190023SA(11)230509, (01)008406821168622(21)TAB23020021SA(11)230110;
60) 2082844-001-987480, UDI: (01)008406821168622(21)TAB23080061SA(11)230224, (01)008406821168622(21)TAB23080062SA(11)230224, (01)008406821168622(21)TAB23080063SA(11)230224, (01)008406821168622(21)TAB23080064SA(11)230224, (01)008406821168622(21)TAB23130010SA(11)230327, (01)008406821168622(21)TAB23130011SA(11)230327;
61) 2082844-001-987855, UDI: (01)00840682116862(21)TABC70022(11)230203, (01)00840682116862(21)TABC70028(11)230203, (01)00840682116862(21)TABC70127(11)230220, (01)00840682116862(21)TABC70144(11)230223, (01)00840682116862(21)TABC70162(11)230227, (01)00840682116862(21)TABC70071(11)230210, (01)00840682116862(21)TABC70100(11)230215, (01)00840682116862(21)TABC70116(11)230216, (01)00840682116862(21)TABC70128(11)230220, (01)00840682116862(21)TABC70134(11)230221, (01)00840682116862(21)TABC70137(11)230222, (01)00840682116862(21)TABC70146(11)230223, (01)00840682116862(21)TABC70158(11)230227, (01)00840682116862(21)TABC70166(11)230228, (01)00840682116862(21)TABC70173(11)230301, (01)00840682116862(21)TABC70178(11)230302, (01)00840682116862(21)TABC70179(11)230302, (01)00840682116862(21)TABC70181(11)230302, (01)00840682116862(21)TABC70198(11)230306, (01)00840682116862(21)TABC70278(11)230317, (01)00840682116862(21)TABC70279(11)230317, (01)00840682116862(21)TABC70280(11)230317, (01)00840682116862(21)TABC70332(11)230331, (01)00840682116862(21)TABC70353(11)230411, (01)00840682116862(21)TABC70365(11)230412, (01)00840682116862(21)TABC70369(11)230412, (01)00840682116862(21)TABC70163(11)230228, (01)00840682116862(21)TABC70286(11)230320, (01)00840682116862(21)TABC70298(11)230322, (01)00840682116862(21)TABC70121(11)230217, (01)00840682116862(21)TABC70139(11)230222, (01)00840682116862(21)TABC70273(11)230316, (01)00840682116862(21)TABC70364(11)230412;
62) 2082844-001-993967, UDI: (01)008406821168622(21)TAB23090043SA(11)230302, (01)008406821168622(21)TAB23160057SA(11)230421;
63) 2082844-001-994441, UDI: (01)00840682116862(21)TABC70376(11)230413, (01)00840682116862(21)TABC70264(11)230315, (01)00840682116862(21)TABC70297(11)230322, (01)00840682116862(21)TABC70266(11)230315, (01)00840682116862(21)TABC70285(11)230317, (01)00840682116862(21)TABC70370(11)230412, (01)00840682116862(21)TABC70375(11)230413;
64) 2082844-001-995782, UDI: (01)008406821168622(21)TAB23050024SA(11)230201, (01)008406821168622(21)TAB23050025SA(11)230201, (01)008406821168622(21)TAB23050026SA(11)230201;
65) 2082844-001-998377, UDI: (01)00840682116862(21)TABC70275(11)230316, (01)00840682116862(21)TABC70170(11)230228, (01)00840682116862(21)TABC70195(11)230306, (01)00840682116862(21)TABC70272(11)230316, (01)00840682116862(21)TABC70303(11)230323, (01)00840682116862(21)TABC70308(11)230324, (01)00840682116862(21)TABC70367(11)230412
|
Recalling Firm/
Manufacturer |
DATEX--OHMEDA, INC.
9900 W Innovation Dr
Wauwatosa WI 53226-4856
|
| For Additional Information Contact | GE HealthCare Service
800-437-1171 |
|---|
Manufacturer Reason
for Recall | Prior to current established manufacturing practices, higher levels of airborne formaldehyde exposure from newly manufactured incubators could be seen during clinical use that would rapidly decrease over a week. Affected customers were notified in June 2023 to run incubators for a week to potentially off gas any residual airborne formaldehyde. The general scientific consensus is that sensory irritation of the eyes is the most sensitive endpoint with respect to exposure to airborne formaldehyde and is the adverse effect clinically experienced at the lowest concentration. |
|---|
FDA Determined
Cause 2 | Component design/selection |
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| Action | GE HealthCare notified its consignees of the issue by letter beginning on 06/06/2023 using a traceable means. The notice explained the issue of potentially higher levels of formaldehyde which rapidly decrease of a week, and instructions on how to accelerate the rate of dissipation if the unit had not yet been put into clinical use.
For questions: contact 1-800-437-1171 or your local GE HealthCare Representative |
|---|
| Quantity in Commerce | 769 units |
|---|
| Distribution | worldwide |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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| 510(K) Database | 510(K)s with Product Code = FMZ
510(K)s with Product Code = FMZ
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