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FDAFDA · Alimentos y medicamentos·N.º oficial Z-3002-2024

Medline Convenience kits labeled as: 1) HEAD & NECK TRAY, Pack Number AM310B ; 2) HEAD & NECK CDS , Pack Number CDS780161K ; 3) HEAD & NECK CDS , Pack Number CDS780161L ; 4) HEAD & NECK PROCEDURE , Pack Number CDS780170R ; 5) HEAD & NECK PROCEDURE , Pack Number CDS780170S ; 6) CAROTID CDS-LF, Pack Number CDS840056N ; 7) CAROTID-LF, Pack Number CDS860039J ; 8) T & A PROCEDURE-LF, Pack Number CDS860047X ; 9) THORACOTOMY CDS , Pack Number CDS920065R ; 10) EAR CDS , Pack Number CDS980089L ; 11) EAR CDS , Pack Number CDS980089M ; 12) EAR CDS , Pack Number CDS980089N ; 13) EAR CDS , Pack Number CDS980089O ; 14) ENDOSCOPY , Pack Number CDS980201R ; 15) TYMPANOPLASTY , Pack Number CDS980203R ; 16) TYMPANOPLASTY , Pack Number CDS980203S ; 17) TYMPANO CDS , Pack Number CDS980374M ; 18) TYMPANO CDS , Pack Number CDS980374O ; 19) TYMPANO CDS , Pack Number CDS980374P ; 20) THORACOTOMY CDS , Pack Number CDS980446T ; 21) SINUS CDS , Pack Number CDS980579D ; 22) EENT-HEAD AND NECK, Pack Number CDS980809K ; 23) EENT-HEAD AND NECK, Pack Number CDS980809L ; 24) EENT-HEAD AND NECK, Pack Number CDS980809M ; 25) FESS PROCEDURE, Pack Number CDS981185B ; 26) CDS981571P, Pack Number CDS981571P ; 27) SINUS CDS-LF, Pack Number CDS981692J ; 28) EAR CDS , Pack Number CDS981985F ; 29) MAJOR EAR , Pack Number CDS982016Q ; 30) MAJOR EAR , Pack Number CDS982016R ; 31) MAJOR EAR , Pack Number CDS982016S ; 32) MAJOR EAR , Pack Number CDS982016T ; 33) SINUS , Pack Number CDS982020O ; 34) SINUS , Pack Number CDS982020P ; 35) SINUS , Pack Number CDS982020R ; 36) NASAL/SEPTAL, Pack Number CDS982049M; 37) NASAL/SEPTAL, Pack Number CDS982049O; 38) T&A CDS-LF, Pack Number CDS982091I ; 39) EAR-EENT CDS, Pack Number CDS982307F ; 40) EAR-EENT CDS, Pack Number CDS982307G ; 41) EAR-EENT CDS, Pack Number CDS982307J ; 42) BASIC ENT CDS-WRMC, Pack Number CDS982329F ; 43) BASIC ENT CDS-WRMC, Pack Number CDS982329G ; 44) BASIC ENT CDS-WRMC, Pack Number CDS982329I ; 45) BASIC ENT CDS-WRMC, Pack Number CDS982329K ; 46) BAPTIST NORTH T&A SINUS CDS , Pack Number CDS982394B ; 47) MINOR HEAD&NECK CDS MRH-LF, Pack Number CDS982598K ; 48) EAR CDS-LF, Pack Number CDS982612B ; 49) T AND A CDS MRH , Pack Number CDS982622L ; 50) CAROTID , Pack Number CDS982638J ; 51) NASAL CDS , Pack Number CDS982655C ; 52) NASAL CDS , Pack Number CDS982655D ; 53) NASAL CDS , Pack Number CDS982655F ; 54) NECK THYROID, Pack Number CDS982692M ; 55) NECK THYROID, Pack Number CDS982692N ; 56) NECK THYROID, Pack Number CDS982692O ; 57) TYMPANOPLASTY , Pack Number CDS982720N ; 58) TYMPANOPLASTY , Pack Number CDS982720P ; 59) TYMPANOPLASTY , Pack Number CDS982720Q ; 60) TYMPANOPLASTY , Pack Number CDS982720R ; 61) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778I ; 62) SWEDISH CHERRY HILL EAR CDS , Pack Number CDS982778J ; 63) SINUS CDS-1 , Pack Number CDS982901F ; 64) MIDDLE EAR CDS, Pack Number CDS982938J ; 65) MIDDLE EAR CDS, Pack Number CDS982938K ; 66) MIDDLE EAR CDS, Pack Number CDS982938L ; 67) MIDDLE EAR CDS, Pack Number CDS982938O ; 68) SMR/RHINO CDS , Pack Number CDS982939L ; 69) SMR/RHINO CDS , Pack Number CDS982939M ; 70) SMR/RHINO CDS , Pack Number CDS982939N ; 71) SMR/RHINO CDS , Pack Number CDS982939Q ; 72) SMR/RHINO CDS , Pack Number CDS982939R ; 73) SMR/RHINO CDS , Pack Number CDS982939S ; 74) T&A CDS , Pack Number CDS982944J ; 75) T&A CDS , Pack Number CDS982944K ; 76) MINOR EAR , Pack Number CDS982989K ; 77) MINOR EAR , Pack Number CDS982989L ; 78) MINOR EAR , Pack Number CDS982989M ; 79) MINOR EAR , Pack Number CDS982989N ; 80) OSTEOTOMY ORAL PROCEDURE, Pack Number CDS983010G ; 81) ENT CDS , Pack Number CDS983035J ; 82) ENT CDS , Pack Number CDS983035L ; 83) ENT CDS , Pack Number CDS983035M ; 84) CHP SINUS ENDOSCOPY CDS , Pack Number CDS983087G ; 85) CHP TYMPMASTOID CDS, Pack Number CDS983088J; 86) HEAD & NECK CDS , Pack Number CDS983126B ; 87) HEAD & NECK CDS , Pack Number CDS983126C ; 88) CAROTID CDS-

Publicado el 18 de septiembre de 2024 · Inicio del retiro: 8 de abril de 2024

Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Qué hacer

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Detalles del retiro

Fabricante
MEDLINE INDUSTRIES, LP - Northfield
Distribuidor
Worldwide distribution.
Lote
AM310B , Lot Number 20BBX607 ; AM310B , Lot Number 20FBO876 ; AM310B , Lot Number 20HBG464 ; AM310B , Lot Number 20HBT869 ; AM310B , Lot Number 20JBW307 ; AM310B , Lot Number 20XBG776 ; CDS780161K , Lot Number 19ABJ175 ; CDS780161K , Lot Number 19CBC247 ; CDS780161K , Lot Number 19DBJ688 ; CDS780161L , Lot Number 21FBM662 ; CDS780161L , Lot Number 21JBO079 ; CDS780161L , Lot Number 21KBU620 ; CDS780161L , Lot Number 22DBN197 ; CDS780161L , Lot Number 22EBE676 ; CDS780161L , Lot Number 22GBA238 ; CDS780161L , Lot Number 19FBZ495 ; CDS780161L , Lot Number 22HBH827 ; CDS780161L , Lot Number 22JBA466 ; CDS780161L , Lot Number 22JBR842 ; CDS780161L , Lot Number 19IBA021 ; CDS780161L , Lot Number 22LBG736 ; CDS780161L , Lot Number 23ABC482 ; CDS780161L , Lot Number 19KBD885 ; CDS780161L , Lot Number 23BBK773 ; CDS780161L , Lot Number 23DBH567 ; CDS780161L , Lot Number 20BBA048 ; CDS780161L , Lot Number 23EBW865 ; CDS780161L , Lot Number 23FBR465 ; CDS780161L , Lot Number 20CBF643 ; CDS780161L , Lot Number 23HBF094 ; CDS780161L , Lot Number 20DBQ527 ; CDS780161L , Lot Number 20EBT660 ; CDS780161L , Lot Number 23JBG854 ; CDS780161L , Lot Number 23KBG199 ; CDS780161L , Lot Number 20GBQ310 ; CDS780161L , Lot Number 20HBW040 ; CDS780161L , Lot Number 20KBQ319 ; CDS780161L , Lot Number 20LBP102 ; CDS780161L , Lot Number 20LBQ550 ; CDS780161L , Lot Number 21CBI795 ; CDS780161L , Lot Number 21DBA543 ; CDS780161L , Lot Number 21EBA173 ; CDS780170R , Lot Number 21HBH210 ; CDS780170R , Lot Number 19ABX183 ; CDS780170R , Lot Number 19CBG446 ; CDS780170R , Lot Number 19DBV563 ; CDS780170R , Lot Number 19GBW741 ; CDS780170R , Lot Number 19IBQ678 ; CDS780170R , Lot Number 20BBE129 ; CDS780170R , Lot Number 20HBH841 ; CDS780170R , Lot Number 20JBY348 ; CDS780170R , Lot Number 20KBE437 ; CDS780170R , Lot Number 21BBN563 ; CDS780170R , Lot Number 21EBO719 ; CDS780170S , Lot Number 21LBU027 ; CDS780170S , Lot Number 22ABC196 ; CDS780170S , Lot Number 22CBT534 ; CDS780170S , Lot Number 22DBB138 ; CDS780170S , Lot Number 22FBY456 ; CDS780170S , Lot Number 22LMJ227 ; CDS780170S , Lot Number 23AMB457 ; CDS780170S , Lot Number 23AMG031 ; CDS780170S , Lot Number 23BMG081 ; CDS840056N , Lot Number 19ABS578 ; CDS840056N , Lot Number 19CBF638 ; CDS840056N , Lot Number 19DBQ238 ; CDS840056N , Lot Number 19FBT067 ; CDS840056N , Lot Number 19JBJ675 ; CDS860039J , Lot Number 21GBL272 ; CDS860039J , Lot Number 20FBR859 ; CDS860039J , Lot Number 20HBH825 ; CDS860039J , Lot Number 20JBI204 ; CDS860039J , Lot Number 20KBJ538 ; CDS860039J , Lot Number 20LBV021 ; CDS860039J , Lot Number 21CBO329 ; CDS860039J , Lot Number 21EBA033 ; CDS860039J , Lot Number 21EBO476 ; CDS860047X , Lot Number 22KBF748 ; CDS860047X , Lot Number 23ABC310 ; CDS860047X , Lot Number 23BBN857 ; CDS860047X , Lot Number 23CBM719 ; CDS860047X , Lot Number 23CBR360 ; CDS860047X , Lot Number 23DBP426 ; CDS860047X , Lot Number 23EBK702 ; CDS860047X , Lot Number 23FBE714 ; CDS860047X , Lot Number 23GBU901 ; CDS860047X , Lot Number 23HBU599 ; CDS860047X , Lot Number 23IBO885 ; CDS920065R , Lot Number 22JLB054 ; CDS980089L , Lot Number 19BBE268 ; CDS980089L , Lot Number 19CBL613 ; CDS980089L , Lot Number 19FBL680 ; CDS980089L , Lot Number 19TBC919 ; CDS980089L , Lot Number 19JBK959 ; CDS980089M , Lot Number 21FBJ093 ; CDS980089M , Lot Number 21FBJ094 ; CDS980089M , Lot Number 21FBJ095 ; CDS980089M , Lot Number 21FBJ096 ; CDS980089M , Lot Number 21FBJ097 ; CDS980089M , Lot Number 21FBR314 ; CDS980089M , Lot Number 21HBG999 ; CDS980089M , Lot Number 21JBM584 ; CDS980089M , Lot Number 19KBH835 ; CDS980089M , Lot Number 20HBU008 ; CDS980089M , Lot Number 20LBI140 ; CDS980089M , Lot Number 21BBJ367 ; CDS980089N , Lot Number 22ABD323 ; CDS980089N , Lot Number 22ABD324 ; CDS980089N , Lot Number 22KBM192 ; CDS980089O , Lot Number 23CBW365 ; CDS980089O , Lot Number 23EBE453 ; CDS980089O , Lot Number 23GB
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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