| | Class 2 Device Recall Medline |  |
| Date Initiated by Firm | September 04, 2024 |
|---|
| Date Posted | October 23, 2024 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0166-2025 |
|---|
| Recall Event ID |
95415 |
| Product Classification |
General surgery tray - Product Code LRO
|
| Product | Medline brand medical procedure convenience kits, labeled as:
1) THORACENTESIS TRAY, REF 00-400616J;
2) HH PACK SONICATION SPEC CONTAI, REF 3706WHST;
3) T&A CDS, REF CDS980427J;
4) EVD CDS, REF CDS984603;
5) CHEST DRAINAGE TRAY, REF CHT745;
6) TRAY FOL TEMP UM 14FR 10ML MF, REF DYND150814TS;
7) TRAY FOL TEMP UM 14FR 10ML MF, REF DYND150814TS;
8) CUSTOM KIT, REF DYNDA2060;
9) CHEST TRAY PACK, REF DYNDA2203;
10) PK LESION CSTM, REF DYNDA2914;
11) BRONCH ESOPHAGOSCOPY PACK, REF DYNDH1765;
12) SOFT TISSUE PACK, REF DYNJ00017M;
13) M1S0579 MANIFLD/CANISTR PK -LF, REF DYNJ0259819I;
14) M1S0579 MANIFLD/CANISTR PK -LF, REF DYNJ0259819I;
15) M1S0579 MANIFLD/CANISTR PK -LF, REF DYNJ0259819I;
16) MINOR PACK-LF, REF DYNJ0410060S;
17) CYSTO I TRAY, REF DYNJ14063D;
18) CYSTO I TRAY, REF DYNJ14063D;
19) CYSTO PACK, REF DYNJ17310D;
20) DENTAL PK-LF, REF DYNJ21241D;
21) CYSTO PACK-LF, REF DYNJ25042I;
22) BASIC PACK-LF, REF DYNJ25450I;
23) BASIC PACK-LF, REF DYNJ25450J;
24) OPS T&A PACK, REF DYNJ26876F;
25) BASIC PACK, REF DYNJ31835G;
26) DENTAL PACK, REF DYNJ32991C;
27) MEDVET PROCEDURE PACK, REF DYNJ34226C;
28) MEDVET PROCEDURE PACK, REF DYNJ34226C;
29) CYSTO, REF DYNJ34527B;
30) UNIVERSAL PACK, REF DYNJ35593D;
31) T&A PACK, REF DYNJ36434A;
32) ENSEMBLE PROCEDURE MINEURE-LF, REF DYNJ38085C;
33) TYMPANOMASTOID PACK, REF DYNJ39342C;
34) OB DELIVERY PACK, REF DYNJ39377C;
35) PK,ENT-T&A, REF DYNJ39548A;
36) PACEMAKER SET UP PACK-LF, REF DYNJ40010B;
37) GENERAL OVERBED PACK, REF DYNJ40045B;
38) GENERAL OVERBED PACK, REF DYNJ40045B;
39) MAJOR OPHTHALMIC, REF DYNJ40317;
40) ENSEMBLE ACCOUCHEMENT-LF, REF DYNJ40933A;
41) ORL TYMPANO PACK BJC-LF, REF DYNJ41674A;
42) TURP PACK BWH-LF, REF DYNJ41706C;
43) TURP PACK BWH-LF, REF DYNJ41706C;
44) CYSTOSCOPY PACK BWH-LF, REF DYNJ41709B;
45) ORAL SURGERY PACK WRO-LF, REF DYNJ41862C;
46) MAJOR CYSTO PACK WRO-LF, REF DYNJ41871B;
47) BASIC SET UP TRAY-LF, REF DYNJ42142A;
48) CHEST TUBE, REF DYNJ42491;
49) BASIC PACK-LF, REF DYNJ43400C;
50) ENT PACK, REF DYNJ43538B;
51) MGASC MINOR PK-22025183, REF DYNJ44818D;
52) GEN SURG - MINOR-LF, REF DYNJ45731A;
53) STERILE FIELD, REF DYNJ46227B;
54) STERILE FIELD, REF DYNJ46227B;
55) BASIC PACK, REF DYNJ47823C;
56) MINOR PACK, REF DYNJ49825C;
57) CYSTO PACK, REF DYNJ50073B;
58) CYSTO PACK, REF DYNJ50073B;
59) 7497 VAT SURGICAL KIT, REF DYNJ50320B;
60) ENSEMBLE CYSTOSCOPIE-LF, REF DYNJ50946A;
61) ENT PACK, REF DYNJ51360;
62) PK-GEN-BASIC, REF DYNJ52220A;
63) MINOR PACK, REF DYNJ52782C;
64) LEG ROLL KIT, REF DYNJ53020;
65) CYSTO PACK-LF, REF DYNJ53204A;
66) TREATMENT ROOM TRAY-LF, REF DYNJ53268;
67) BASIC SET UP PK, REF DYNJ53509B;
68) T AND A PACK, REF DYNJ54087A;
69) TUR PACK, REF DYNJ54483A;
70) FTMC LOCAL PACK-LF, REF DYNJ54607B;
71) TONSIL PACK, REF DYNJ54765C;
72) SPINAL CORD STIMULATION, REF DYNJ57294;
73) T&A PACK, REF DYNJ57810;
74) PROCEDURE PACK, REF DYNJ58538;
75) ENSEMBLE MAIN/POIGNET, REF DYNJ59375;
76) MINOR PACK, REF DYNJ59621A;
77) CYSTO, REF DYNJ60307A;
78) MEDVET PROCEDURE PACK, REF DYNJ60368B;
79) DR. HUNT PACK, REF DYNJ61218;
80) CYSTO PACK, REF DYNJ61506A;
81) SLCH DIGITAL XRAY PACK, REF DYNJ61664A;
82) MHPB CONVERSION PACK, REF DYNJ62027A;
83) SMALL PROCEDURE PACK, REF DYNJ62231;
84) DENTAL PACK, REF DYNJ62619A;
85) BASIC PACK-LF, REF DYNJ63522A;
86) BASIC PACK, REF DYNJ64865;
87) INFERTILITY PACK, REF DYNJ65720;
88) SETUP PACK, REF DYNJ67675A;
89) TLPO PACK, REF DYNJ68312;
90) SURGERY PACK, REF DYNJ68458;
91) KF PACK 2.0, REF DYNJ69619;
92) SURGERY PACK, REF DYNJ69692;
93) DR GREEN PACK, REF DYNJ80043;
94) DRAPE PACK II, REF DYNJ80154B;
95) UNIVERSAL PACK, REF DYNJ80178A;
96) GENERAL SURGERY PACK, REF DYNJ80194;
97) SUPPLEMENT MIPS PK, REF DYNJ80244C;
98) UNIVERSAL PACK, REF DYNJ80401A;
99) UNIVERSAL PACK, REF DYNJ80401A;
100) LITHOTOMY PACK, REF DYNJ80765;
101) PKY LITHOTOMY PACK, REF DYNJ81656A;
102) SOFT TISSUE PACK, REF DYNJ82029;
103) MAJOR SURGI |
|---|
| Code Information |
1) REF 00-400616J, UDI/DI 40193489592246 (each), 10193489592245 (case), Lot Numbers: 24ABI725;
2) REF 3706WHST, UDI/DI 40193489445702 (each), 10193489445701 (case), Lot Numbers: 24ABG100;
3) REF CDS980427J, UDI/DI 40889942823575 (each), 10889942823574 (case), Lot Numbers: 24DBG751;
4) REF CDS984603, UDI/DI 40884389853789 (each), 10884389853788 (case), Lot Numbers: 24BBB784;
5) REF CHT745, UDI/DI 40653160263655 (each), 10653160263654 (case), Lot Numbers: 23LBM800;
6) REF DYND150814TS, UDI/DI 40195327149704 (each), 10195327149703 (case), Lot Numbers: 23KBD258;
7) REF DYND150814TS, UDI/DI 40195327149704 (each), 10195327149703 (case), Lot Numbers: 23KBA940;
8) REF DYNDA2060, UDI/DI 40889942697336 (each), 10889942697335 (case), Lot Numbers: 24ABN606;
9) REF DYNDA2203, UDI/DI 40889942813774 (each), 10889942813773 (case), Lot Numbers: 24ABD615;
10) REF DYNDA2914, UDI/DI 40195327092802 (each), 10195327092801 (case), Lot Numbers: 23LBL366;
11) REF DYNDH1765, UDI/DI 40195327205769 (each), 10195327205768 (case), Lot Numbers: 24ABG092;
12) REF DYNJ00017M, UDI/DI 40195327492039 (each), 10195327492038 (case), Lot Numbers: 24ABD093;
13) REF DYNJ0259819I, UDI/DI 40193489972901 (each), 10193489972900 (case), Lot Numbers: 24ABB267;
14) REF DYNJ0259819I, UDI/DI 40193489972901 (each), 10193489972900 (case), Lot Numbers: 23KBO771;
15) REF DYNJ0259819I, UDI/DI 40193489972901 (each), 10193489972900 (case), Lot Numbers: 23JBS007;
16) REF DYNJ0410060S, UDI/DI 40195327440894 (each), 10195327440893 (case), Lot Numbers: 23LBR879;
17) REF DYNJ14063D, UDI/DI 40884389873619 (each), 10884389873618 (case), Lot Numbers: 24ABF481;
18) REF DYNJ14063D, UDI/DI 40884389873619 (each), 10884389873618 (case), Lot Numbers: 23LBN035;
19) REF DYNJ17310D, UDI/DI 40193489775403 (each), 10193489775402 (case), Lot Numbers: 23LBK791;
20) REF DYNJ21241D, UDI/DI 40884389838878 (each), 10884389838877 (case), Lot Numbers: 23LBL798;
21) REF DYNJ25042I, UDI/DI 40889942802426 (each), 10889942802425 (case), Lot Numbers: 23LBS919;
22) REF DYNJ25450I, UDI/DI 40889942136200 (each), 10889942136209 (case), Lot Numbers: 23KBE169;
23) REF DYNJ25450J, UDI/DI 40195327573677 (each), 10195327573676 (case), Lot Numbers: 24ABG313;
24) REF DYNJ26876F, UDI/DI 40884389608150 (each), 10884389608159 (case), Lot Numbers: 24ABC156;
25) REF DYNJ31835G, UDI/DI 40193489705509 (each), 10193489705508 (case), Lot Numbers: 24ABD033;
26) REF DYNJ32991C, UDI/DI 40889942913658 (each), 10889942913657 (case), Lot Numbers: 23LBL686;
27) REF DYNJ34226C, UDI/DI 40888277762306 (each), 10888277762305 (case), Lot Numbers: 23LBL752;
28) REF DYNJ34226C, UDI/DI 40888277762306 (each), 10888277762305 (case), Lot Numbers: 23KBE103;
29) REF DYNJ34527B, UDI/DI 40193489668255 (each), 10193489668254 (case), Lot Numbers: 24ABE279;
30) REF DYNJ35593D, UDI/DI 40193489928182 (each), 10193489928181 (case), Lot Numbers: 23LBI864;
31) REF DYNJ36434A, UDI/DI 40888277057730 (each), 10888277057739 (case), Lot Numbers: 24ABB540;
32) REF DYNJ38085C, UDI/DI 40889942671169 (each), 10889942671168 (case), Lot Numbers: 23LBR333;
33) REF DYNJ39342C, UDI/DI 40889942353423 (each), 10889942353422 (case), Lot Numbers: 23LBR035;
34) REF DYNJ39377C, UDI/DI 40888277760135 (each), 10888277760134 (case), Lot Numbers: 23KBF280;
35) REF DYNJ39548A, UDI/DI 40884389909141 (each), 10884389909140 (case), Lot Numbers: 24ABB335;
36) REF DYNJ40010B, UDI/DI 40889942908678 (each), 10889942908677 (case), Lot Numbers: 23KBA116;
37) REF DYNJ40045B, UDI/DI 40889942683919 (each), 10889942683918 (case), Lot Numbers: 23LBM922;
38) REF DYNJ40045B, UDI/DI 40889942683919 (each), 10889942683918 (case), Lot Numbers: 23KBF156;
39) REF DYNJ40317, UDI/DI 40884389850474 (each), 10884389850473 (case), Lot Numbers: 24ABC781;
40) REF DYNJ40933A, UDI/DI 40193489845359 (each), 10193489845358 (case), Lot Numbers: 23LBM102;
41) REF DYNJ41674A, UDI/DI 40889942860129 (each), 10889942860128 (case), Lot Numbers: 24ABB568;
42) REF DYNJ41706C, UDI/DI 40193489662796 (each), 10193489662795 (case), Lot Numbers: 24ABG266;
43) REF DYNJ41706C, UDI/DI 40193489662796 (each), 10193489662795 (case), Lot Numbers: 23LBR757;
44) REF DYNJ41709B, UDI/DI 40888277284440 (each), 10888277284449 (case), Lot Numbers: 23LBK417;
45) REF DYNJ41862C, UDI/DI 40193489676922 (each), 10193489676921 (case), Lot Numbers: 23KBF154;
46) REF DYNJ41871B, UDI/DI 40193489662017 (each), 10193489662016 (case), Lot Numbers: 23KBN364;
47) REF DYNJ42142A, UDI/DI 40888277831187 (each), 10888277831186 (case), Lot Numbers: 24ABA117;
48) REF DYNJ42491, UDI/DI 40884389925035 (each), 10884389925034 (case), Lot Numbers: 24ABB278;
49) REF DYNJ43400C, UDI/DI 40193489447744 (each), 10193489447743 (case), Lot Numbers: 23LBU893;
50) REF DYNJ43538B, UDI/DI 40888277584137 (each), 10888277584136 (case), Lot Numbers: 23LBV457;
51) REF DYNJ44818D, UDI/DI 40193489984133 (each), 10193489984132 (case), Lot Numbers: 23KBT511;
52) REF DYNJ45731A, UDI/DI 40889942637721 (each), 10889942637720 (case), Lot Numbers: 24ABD039;
53) REF DYNJ46227B, UDI/DI 40193489854436 (each), 10193489854435 (case), Lot Numbers: 24ABM200;
54) REF DYNJ46227B, UDI/DI 40193489854436 (each), 10193489854435 (case), Lot Numbers: 24ABA452;
55) REF DYNJ47823C, UDI/DI 40193489956789 (each), 10193489956788 (case), Lot Numbers: 24ABB573;
56) REF DYNJ49825C, UDI/DI 40193489506397 (each), 10193489506396 (case), Lot Numbers: 23KBB473;
57) REF DYNJ50073B, UDI/DI 40193489208055 (each), 10193489208054 (case), Lot Numbers: 23LBU510;
58) REF DYNJ50073B, UDI/DI 40193489208055 (each), 10193489208054 (case), Lot Numbers: 23KBD577;
59) REF DYNJ50320B, UDI/DI 40193489349697 (each), 10193489349696 (case), Lot Numbers: 24ABA672;
60) REF DYNJ50946A, UDI/DI 40889942671237 (each), 10889942671236 (case), Lot Numbers: 24ABG215;
61) REF DYNJ51360, UDI/DI 40889942158639 (each), 10889942158638 (case), Lot Numbers: 24ABB279;
62) REF DYNJ52220A, UDI/DI 40889942581963 (each), 10889942581962 (case), Lot Numbers: 23LBP897;
63) REF DYNJ52782C, UDI/DI 40193489568654 (each), 10193489568653 (case), Lot Numbers: 23LBP253;
64) REF DYNJ53020, UDI/DI 40889942361220 (each), 10889942361229 (case), Lot Numbers: 24ABE280;
65) REF DYNJ53204A, UDI/DI 40889942394662 (each), 10889942394661 (case), Lot Numbers: 24ABG188;
66) REF DYNJ53268, UDI/DI 40889942394938 (each), 10889942394937 (case), Lot Numbers: 23KBD061;
67) REF DYNJ53509B, UDI/DI 40195327467945 (each), 10195327467944 (case), Lot Numbers: 24ABA330;
68) REF DYNJ54087A, UDI/DI 40193489528788 (each), 10193489528787 (case), Lot Numbers: 23LBL773;
69) REF DYNJ54483A, UDI/DI 40889942620990 (each), 10889942620999 (case), Lot Numbers: 24ABG233;
70) REF DYNJ54607B, UDI/DI 40195327456680 (each), 10195327456689 (case), Lot Numbers: 23LBV155;
71) REF DYNJ54765C, UDI/DI 40195327550012 (each), 10195327550011 (case), Lot Numbers: 24ABG401;
72) REF DYNJ57294, UDI/DI 40889942737407 (each), 10889942737406 (case), Lot Numbers: 24ABG021;
73) REF DYNJ57810, UDI/DI 40889942779117 (each), 10889942779116 (case), Lot Numbers: 23LBM155;
74) REF DYNJ58538, UDI/DI 40889942866404 (each), 10889942866403 (case), Lot Numbers: 23KBI131;
75) REF DYNJ59375, UDI/DI 40888277736116 (each), 10888277736115 (case), Lot Numbers: 23LBM752;
76) REF DYNJ59621A, UDI/DI 40193489685375 (each), 10193489685374 (case), Lot Numbers: 23KBC997;
77) REF DYNJ60307A, UDI/DI 40193489691703 (each), 10193489691702 (case), Lot Numbers: 24ABE301;
78) REF DYNJ60368B, UDI/DI 40195327168613 (each), 10195327168612 (case), Lot Numbers: 23KBC801;
79) REF DYNJ61218, UDI/DI 40193489548885 (each), 10193489548884 (case), Lot Numbers: 23LBL020;
80) REF DYNJ61506A, UDI/DI 40193489783255 (each), 10193489783254 (case), Lot Numbers: 24ABC133;
81) REF DYNJ61664A, UDI/DI 40193489470261 (each), 10193489470260 (case), Lot Numbers: 23KBC463;
82) REF DYNJ62027A, UDI/DI 40193489626842 (each), 10193489626841 (case), Lot Numbers: 24ABG214;
83) REF DYNJ62231, UDI/DI 40193489637220 (each), 10193489637229 (case), Lot Numbers: 23KBD005;
84) REF DYNJ62619A, UDI/DI 40193489358286 (each), 10193489358285 (case), Lot Numbers: 24ABE270;
85) REF DYNJ63522A, UDI/DI 40195327428199 (each), 10195327428198 (case), Lot Numbers: 23LBU500;
86) REF DYNJ64865, UDI/DI 40193489224918 (each), 10193489224917 (case), Lot Numbers: 23KBD860;
87) REF DYNJ65720, UDI/DI 40193489285179 (each), 10193489285178 (case), Lot Numbers: 23LBP965;
88) REF DYNJ67675A, UDI/DI 40195327366231 (each), 10195327366230 (case), Lot Numbers: 23LBS280;
89) REF DYNJ68312, UDI/DI 40193489821940 (each), 10193489821949 (case), Lot Numbers: 24ABG206;
90) REF DYNJ68458, UDI/DI 40193489463195 (each), 10193489463194 (case), Lot Numbers: 23LBN052;
91) REF DYNJ69619, UDI/DI 40193489959445 (each), 10193489959444 (case), Lot Numbers: 23KBE167;
92) REF DYNJ69692, UDI/DI 40193489970211 (each), 10193489970210 (case), Lot Numbers: 23KBF303;
93) REF DYNJ80043, UDI/DI 40195327010769 (each), 10195327010768 (case), Lot Numbers: 24ABC517;
94) REF DYNJ80154B, UDI/DI 40195327218912 (each), 10195327218911 (case), Lot Numbers: 23KBR662;
95) REF DYNJ80178A, UDI/DI 40195327296842 (each), 10195327296841 (case), Lot Numbers: 24ABC430;
96) REF DYNJ80194, UDI/DI 40195327014187 (each), 10195327014186 (case), Lot Numbers: 23LBM855;
97) REF DYNJ80244C, UDI/DI 40195327542024 (each), 10195327542023 (case), Lot Numbers: 23LBP429;
98) REF DYNJ80401A, UDI/DI 40195327239573 (each), 10195327239572 (case), Lot Numbers: 23LBP471;
99) REF DYNJ80401A, UDI/DI 40195327239573 (each), 10195327239572 (case), Lot Numbers: 23KBE914;
100) REF DYNJ80765, UDI/DI 40195327074969 (each), 10195327074968 (case), Lot Numbers: 23KBB377;
101) REF DYNJ81656A, UDI/DI 40195327498499 (each), 10195327498498 (case), Lot Numbers: 23KBD944;
102) REF DYNJ82029, UDI/DI 40195327162109 (each), 10195327162108 (case), Lot Numbers: 23KBC835;
103) REF DYNJ82427, UDI/DI 40195327194582 (each), 10195327194581 (case), Lot Numbers: 23LBV375;
104) REF DYNJ82500B, UDI/DI 40195327373086 (each), 10195327373085 (case), Lot Numbers: 23LBO296;
105) REF DYNJ82500B, UDI/DI 40195327373086 (each), 10195327373085 (case), Lot Numbers: 23LBM804;
106) REF DYNJ82700D, UDI/DI 40195327561254 (each), 10195327561253 (case), Lot Numbers: 23LBM966;
107) REF DYNJ82715, UDI/DI 40195327204304 (each), 10195327204303 (case), Lot Numbers: 24ABC127;
108) REF DYNJ82850A, UDI/DI 40195327244812 (each), 10195327244811 (case), Lot Numbers: 24ABD666;
109) REF DYNJ82873, UDI/DI 40195327213153 (each), 10195327213152 (case), Lot Numbers: 23LBL690;
110) REF DYNJ83203, UDI/DI 40195327244553 (each), 10195327244552 (case), Lot Numbers: 23LBP730;
111) REF DYNJ83250, UDI/DI 40195327248612 (each), 10195327248611 (case), Lot Numbers: 23KBF282;
112) REF DYNJ83330, UDI/DI 40195327262151 (each), 10195327262150 (case), Lot Numbers: 23LBP731;
113) REF DYNJ83596, UDI/DI 40195327284443 (each), 10195327284442 (case), Lot Numbers: 24ABD078;
114) REF DYNJ84440, UDI/DI 40195327365128 (each), 10195327365127 (case), Lot Numbers: 23LBV275;
115) REF DYNJ85234, UDI/DI 40195327481392 (each), 10195327481391 (case), Lot Numbers: 23LBL820;
116) REF DYNJ85234, UDI/DI 40195327481392 (each), 10195327481391 (case), Lot Numbers: 23KBF800;
117) REF DYNJ85628, UDI/DI 40195327526697 (each), 10195327526696 (case), Lot Numbers: 23LBV274;
118) REF DYNJ85709, UDI/DI 40195327537600 (each), 10195327537609 (case), Lot Numbers: 24ABK573;
119) REF DYNJ900120F, UDI/DI 40193489851343 (each), 10193489851342 (case), Lot Numbers: 24ABS299;
120) REF DYNJ907048A, UDI/DI 40193489370288 (each), 10193489370287 (case), Lot Numbers: 24BBC990;
121) REF DYNJ909048, UDI/DI 40195327257775 (each), 10195327257774 (case), Lot Numbers: 24ABC721;
122) REF DYNJ909048, UDI/DI 40195327257775 (each), 10195327257774 (case), Lot Numbers: 23KBP667;
123) REF DYNJ909288A, UDI/DI 40195327488278 (each), 10195327488277 (case), Lot Numbers: 24CBA276;
124) REF DYNJ909288A, UDI/DI 40195327488278 (each), 10195327488277 (case), Lot Numbers: 24ABW976;
125) REF DYNJCH914, UDI/DI 40193489448284 (each), 10193489448283 (case), Lot Numbers: 23LBP583;
126) REF DYNJCH914, UDI/DI 40193489448284 (each), 10193489448283 (case), Lot Numbers: 23KBB451;
127) REF DYNJHTLD01, UDI/DI 40888277079077 (each), 10888277079076 (case), Lot Numbers: 23LBV200;
128) REF DYNJHTLD01, UDI/DI 40888277079077 (each), 10888277079076 (case), Lot Numbers: 23KBD588;
129) REF DYNJS0900, UDI/DI 40884389235110 (each), 10884389235119 (case), Lot Numbers: 23KBF916;
130) REF GSD349J, UDI/DI 40884389921709 (each), 10884389921708 (case), Lot Numbers: 23LBM389;
131) REF KC4716D, UDI/DI 40888277200914 (each), 10888277200913 (case), Lot Numbers: 23LBL672;
132) REF LYN030DBEYA, UDI/DI 40193489286152 (each), 10193489286151 (case), Lot Numbers: 23LBN466;
133) REF LYN030DBEYA, UDI/DI 40193489286152 (each), 10193489286151 (case), Lot Numbers: 23KBD390;
134) REF MNS13650, UDI/DI 40653160992487 (each), 10653160992486 (case), Lot Numbers: 23LBH905;
135) REF MNS13935A, UDI/DI 40653160996089 (each), 10653160996088 (case), Lot Numbers: 24ABB393;
136) REF MNS15265, UDI/DI 40653160996164 (each), 10653160996163 (case), Lot Numbers: 23LBR564;
137) REF SYNJ910010A, UDI/DI 40889942846987 (each), 10889942846986 (case), Lot Numbers: 24BBI539;
138) REF VAL005BACFA, UDI/DI 40193489261951 (each), 10193489261950 (case), Lot Numbers: 24ABA923;
139) REF VAL009EYCHA, UDI/DI 40193489426077 (each), 10193489426076 (case), Lot Numbers: 24ABA896;
140) REF VAL009TVSGA, UDI/DI 40193489577564 (each), 10193489577563 (case), Lot Numbers: 23LBQ095;
141) REF VAL071GTHFA, UDI/DI 40193489897334 (each), 10193489897333 (case), Lot Numbers: 24ABA928;
142) REF VAL089RIRUA, UDI/DI 40193489438179 (each), 10193489438178 (case), Lot Numbers: 24ABF322
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Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
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| For Additional Information Contact | Karin Johnson
866-359-1704 |
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Manufacturer Reason
for Recall | XXX |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees. |
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| Quantity in Commerce | 22,327 units |
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| Distribution | Worldwide distribution - US Nationwide and the countries of Canada, Panama. |
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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.
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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