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FDAFDA · Alimentos y medicamentos·N.º oficial Z-2747-2024

Medline procedural kits labeled as: 1) TYMPANOPLASTY , Pack Number CDS980203S; 2) MAJOR EAR , Pack Number CDS982016T; 3) MAJOR EAR PACK, Pack Number CMPJ01846O; 4) EAR PACK, Pack Number CMPJ05884J; 5) MZ EAR PACK , Pack Number CMPJ09860D; 6) KIT MAJOR EAR CHRG, Pack Number CMPJ09914C; 7) ENT PACK, Pack Number CMPJ13389A; 8) ENT PACK, Pack Number CMPJ13389B; 9) ENT PACK, Pack Number CMPJ13389C; 10) DR LIN EAR PACK , Pack Number CMPJ13509 ; 11) TYMPANOPLASTY PACK, Pack Number CMPJ21114O; 12) EAR PACK-LF , Pack Number DYNJ0425965G ; 13) EAR PACK-LF , Pack Number DYNJ0774664K ; 14) HL EAR PACK , Pack Number DYNJ40560B; 15) HL EAR PACK , Pack Number DYNJ40560BH; 16) EAR PACK, Pack Number DYNJ44134C; 17) EAR PACK, Pack Number DYNJ44134D; 18) EAR PACK, Pack Number DYNJ44134F; 19) MINOR ENT PACK, Pack Number DYNJ45577A; 20) ENT PACK, Pack Number DYNJ48595 ; 21) MH NASAL, Pack Number DYNJ49888I; 22) MH NASAL, Pack Number DYNJ49888J; 23) MIDDLE EAR OR , Pack Number DYNJ52583G; 24) MIDDLE EAR OR , Pack Number DYNJ52583J; 25) MIDDLE EAR OR , Pack Number DYNJ52583L; 26) ***, Pack Number DYNJ52583M; 27) GLENNON HEAD AND NECK PACK-LF , Pack Number DYNJ57200A; 28) MIDDLE EAR PACK , Pack Number DYNJ65935A; 29) ENT PACK, Pack Number DYNJ66039B; 30) FACIAL PACK , Pack Number DYNJ82177B; 31) FACIAL PACK , Pack Number DYNJ82177BH; 32) EAR CUSTOM PACK , Pack Number DYNJ82564 ; 33) ***, Pack Number DYNJ86113 ; 34) EAR , Pack Number DYNJ901779J; 35) MZ EAR CDS, Pack Number DYNJ905642D; 36) PACK MAJOR EAR CHRG , Pack Number DYNJ905694C; 37) ENT , Pack Number DYNJ909128A; 38) ENT , Pack Number DYNJ909128C; 39) ENT , Pack Number DYNJ909128D; 40) ***, Pack Number DYNJ909128D; 41) DR LIN EAR, Pack Number DYNJ909251; 42) T AND A , Pack Number DYNJ909941; 43) ***, Pack Number DYNJ909941

Publicado el 4 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
Lote
CDS980203S, Lot Numbers:23DBT154; CDS980203S, Lot Numbers:23HBT797; CDS980203S, Lot Numbers:23JBM122; CDS980203S, Lot Numbers:23LBC884; CDS980203S, Lot Numbers:21CBW683; CDS982016T, Lot Numbers:22GBM951; CDS982016T, Lot Numbers:22GBO165; CDS982016T, Lot Numbers:22HBS644; CMPJ01846O, Lot Numbers:21LBQ988; CMPJ01846O, Lot Numbers:22FBV101; CMPJ05884J, Lot Numbers:21KBO037; CMPJ05884J, Lot Numbers:21KBU691; CMPJ05884J, Lot Numbers:21LBH778; CMPJ05884J, Lot Numbers:22IBG052; CMPJ05884J, Lot Numbers:22JBN865; CMPJ09860D, Lot Numbers:23KMB793; CMPJ09914C, Lot Numbers:23IDA209; CMPJ13389A, Lot Numbers:23CBL552; CMPJ13389B, Lot Numbers:23IBC818; CMPJ13389C, Lot Numbers:23KBU012; CMPJ13389C, Lot Numbers:23LBF106; CMPJ13389C, Lot Numbers:24ABD504; CMPJ13389C, Lot Numbers:24ABY610; CMPJ13389C, Lot Numbers:24BBV889; CMPJ13509, Lot Numbers:23IBF142; CMPJ21114O, Lot Numbers:23BBQ474; CMPJ21114O, Lot Numbers:23HBG033; CMPJ21114O, Lot Numbers:23IBV766; CMPJ21114O, Lot Numbers:23JBM292; CMPJ21114O, Lot Numbers:23KBK531; CMPJ21114O, Lot Numbers:21BBJ985; DYNJ0425965G, Lot Numbers:23GMH984; DYNJ0774664K, Lot Numbers:23HBP871; DYNJ40560B, Lot Numbers:23HBF219; DYNJ40560BH , Lot Numbers:23HBF219; DYNJ44134C, Lot Numbers:22JBQ075; DYNJ44134D, Lot Numbers:23BBK410; DYNJ44134D, Lot Numbers:23CBS145; DYNJ44134F, Lot Numbers:23EBC602; DYNJ44134F, Lot Numbers:23GBV482; DYNJ44134F, Lot Numbers:23JBP398; DYNJ44134F, Lot Numbers:23KBN024; DYNJ44134F, Lot Numbers:24ABC027; DYNJ45577A, Lot Numbers:21KBL221; DYNJ45577A, Lot Numbers:21KBT524; DYNJ48595, Lot Numbers:24BBO457; DYNJ49888I, Lot Numbers:22AMG372; DYNJ49888I, Lot Numbers:22KMD386; DYNJ49888J, Lot Numbers:24AMG698; DYNJ52583G, Lot Numbers:21HBC324; DYNJ52583G, Lot Numbers:21KBM269; DYNJ52583J, Lot Numbers:21LBN305; DYNJ52583L, Lot Numbers:22DBB163; DYNJ52583L, Lot Numbers:22FBF207; DYNJ52583L, Lot Numbers:22HMF439; DYNJ52583L, Lot Numbers:22JMC614; DYNJ52583L, Lot Numbers:23JMF994; DYNJ52583M, Lot Numbers:24CMF962; DYNJ57200A, Lot Numbers:23HBN488; DYNJ65935A, Lot Numbers:23HBR355; DYNJ65935A, Lot Numbers:23HBT376; DYNJ66039B, Lot Numbers:23GBQ016; DYNJ82177B, Lot Numbers:23KMB826; DYNJ82177BH , Lot Numbers:23KMB826; DYNJ82564, Lot Numbers:23GBV431; DYNJ86113, Lot Numbers:24CBE092; DYNJ901779J , Lot Numbers:21KBY716; DYNJ901779J , Lot Numbers:21LBS995; DYNJ901779J , Lot Numbers:21LBV102; DYNJ901779J , Lot Numbers:22IBS613; DYNJ901779J , Lot Numbers:22JBY312; DYNJ901779J , Lot Numbers:22JBY313; DYNJ901779J , Lot Numbers:23BBB017; DYNJ905642D , Lot Numbers:23KMH482; DYNJ905694C , Lot Numbers:23IDB849; DYNJ909128A , Lot Numbers:23DBD851; DYNJ909128C , Lot Numbers:23JBO251; DYNJ909128D , Lot Numbers:23LBM416; DYNJ909128D , Lot Numbers:23LBQ695; DYNJ909128D , Lot Numbers:24ABR742; DYNJ909128D , Lot Numbers:24BBM816; DYNJ909128D , Lot Numbers:24CBK211; DYNJ909251, Lot Numbers:23IBT842; DYNJ909251, Lot Numbers:23IBT854; DYNJ909251, Lot Numbers:23IBV449; DYNJ909251, Lot Numbers:23JBT806; DYNJ909941, Lot Numbers:23JBH984; DYNJ909941, Lot Numbers:24ABD605; DYNJ909941, Lot Numbers:24ABD695; DYNJ909941, Lot Numbers:24ABT569; DYNJ909941, Lot Numbers:24CBK472
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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