FDAFDA · Food and drugs·Recall number Z-0166-2025
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
Published October 30, 2024 · Recall initiated: September 4, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
XXX
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada, Panama.
- Lot
- 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: 24
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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