Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICAT
Summary
The FDA issued a Class II for Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS T by MEDLINE INDUSTRIES, LP - Northfield. Reason: XXX.
Details
Source
Device Recall
External ID
Z-0166-2025
Action Date
2024-10-30
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: 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
Quantity Affected: 22,327 units
Reason for Recall
XXX
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-04
Company
Northfield, IL
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 253 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 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 (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0166-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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