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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0645-2025

MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V; 2) C-SECTION OR 30 CDS, REF CDS820075W; 3) C-SECTION, REF CDS980774M; 4) C-SECTION KIT, REF CDS981322AB; 5) C-SECTION KIT, REF CDS981322AC; 6) C-SECTION COMBINED CDS, REF CDS982398I; 7) C-SECTION PROCEDURE, REF CDS983450L; 8) C-SECTION-LF, REF CDS983869J; 9) C-SECTION, REF CDS984261J; 10) C-SECTION CDS-LF, REF CDS984516L; 11) C-SECTION CDS-LF, REF CDS984516M; 12) C-SECTION, REF CDS984902K; 13) C-SECTION, REF CDS984902L; 14) C-SECTION CDS, REF CDS985282F; 15) C-SECTION CDS, REF CDS985326G; 16) C SECTION, REF CDS985505G; 17) C-SECTION, REF CDSCCR611Q; 18) C-SEC GERBERUNI PK RFID-LF, REF DYNJ0100978K; 19) C-SECTION PACK-LF, REF DYNJ0101147G; 20) BR C-SECTION-LF, REF DYNJ0101562I; 21) BR C-SEC RFID-LF, REF DYNJ0101562K; 22) LUD C-SEC RFID-LF, REF DYNJ0101616L; 23) C-SECTION PACK-LF, REF DYNJ0173422AF; 24) C-SECTION PACK-LF, REF DYNJ0173422AG; 25) C-SECTION PACK-LF, REF DYNJ0190625Q; 26) C-SECTION PACK, REF DYNJ02577D; 27) SUT C-SECTION PACK, REF DYNJ02748F; 28) C-SECTION PACK-LF, REF DYNJ0282506N; 29) C-BIRTH PACK-LF, REF DYNJ0366291O; 30) C SECTION PACK-LF, REF DYNJ0378325M; 31) C SECTION PACK-LF, REF DYNJ0378325N; 32) C SECTION PACK-LF, REF DYNJ0451410O; 33) C-SECTION PACK-LF, REF DYNJ0536924T; 34) C-SECTION PACK-LF, REF DYNJ0536924U; 35) C-SECTION PACK-LF, REF DYNJ0551169V; 36) C-SECTION PACK-LF, REF DYNJ0551409O; 37) LAKELAND C-SECTION PACK-LF, REF DYNJ0619806K; 38) LKLND C-SEC PK RFID-LF, REF DYNJ0619806O; 39) C-SECTION PACK-LF, REF DYNJ0778455D; 40) C-SECTION PACK-LF, REF DYNJ0778455F; 41) C-SECTION PACK-LF, REF DYNJ0778455G; 42) C-SECTION PACK-LF, REF DYNJ07836Q; 43) C-SECTION PACK-LF, REF DYNJ0842739L; 44) C-SECTION PACK-LF, REF DYNJ0842739M; 45) C SECTION PACK-LF, REF DYNJ0854363I; 46) C SECTION PACK-LF, REF DYNJ0854363J; 47) C-SECTION PACK-LF, REF DYNJ0868053S; 48) C-SECTION TRAY-LF, REF DYNJ09174O; 49) C-SECTION TRAY, REF DYNJ16026G; 50) C-SECTION TRAY, REF DYNJ16026I; 51) C-SECTION PACK, REF DYNJ16614B; 52) C-SECTION PACK, REF DYNJ19417P; 53) C-SECTION PACK, REF DYNJ19417Q; 54) C-SECTION PACK, REF DYNJ19417R; 55) C-SECTION PACK-LF, REF DYNJ21569I; 56) C-SECTION PACK, REF DYNJ23432I; 57) C-SECTION LF-OR, REF DYNJ24232I; 58) C-SECTION LF-OR, REF DYNJ24232J; 59) SVMMC C-SECTION PACK, REF DYNJ24632K; 60) ST. CHARLES C-SECTION PACK, REF DYNJ24710I; 61) C-SECTION PACK, REF DYNJ25939N; 62) C-SECTION PACK, REF DYNJ26693M; 63) C-SECTION PACK, REF DYNJ30064O; 64) C-SECTION PACK, REF DYNJ30064P; 65) C-SECTION PACK, REF DYNJ32229M; 66) C-SECTION PACK, REF DYNJ32229N; 67) C-SECTION PACK, REF DYNJ32229O; 68) CUH C-SECTION PACK-LF, REF DYNJ32253G; 69) C-SECTION PACK, REF DYNJ32632F; 70) C-SECTION PACK-LF, REF DYNJ33059B; 71) C SECTION, REF DYNJ37535C; 72) C-SECTION PACK-LF, REF DYNJ37606J; 73) C-SECTION PACK SC-LF, REF DYNJ38063D; 74) C-SECTION PACK, REF DYNJ38229C; 75) C-SECTION PACK SC-LF, REF DYNJ38700G; 76) C-SECTION PACK-LF, REF DYNJ38845D; 77) C SECTION PACK, REF DYNJ43024D; 78) C SECTION PACK, REF DYNJ43024G; 79) C-SECTION PACK-CC, REF DYNJ43146F; 80) C-SECTION PACK, REF DYNJ44679L; 81) C-SECTION PACK, REF DYNJ44773S; 82) C-SECTION PACK, REF DYNJ44773T; 83) C-SECTION PACK, REF DYNJ44773U; 84) NMH C-SECTION PACK, REF DYNJ44773V; 85) C-SECTION PACK, REF DYNJ44861K; 86) C-SECTION TRAY, REF DYNJ46470F; 87) C-SECTION DELIVERY PACK-LF, REF DYNJ47808D; 88) C-SECTION DELIVERY PACK-LF, REF DYNJ47808F; 89) C SECTION PACK, REF DYNJ48087F; 90) WMC C-SECTION PACK-LF, REF DYNJ50655I; 91) C-SECTION I, REF DYNJ51354B; 92) C SECTION PACK, REF DYNJ51872D; 93) C SECTION PACK-LF, REF DYNJ52387M; 94) C SECT PK RFID-LF, REF DYNJ52387N; 95) C-SECTION PACK, REF DYNJ53528C; 96) C SECTION, REF DYNJ53654F; 97) C SECTION, REF DYNJ53654G; 98) C SECTION PACK, REF DYNJ54148D; 99) C SECTION PACK-LF, REF DYNJ54374J; 100) CMH C SECTION PACK-LF, REF DYNJ54374L; 101) MAG C-SECTION PREP

Publicado el 11 de diciembre de 2024 · Inicio del retiro: 9 de octubre 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

Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

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
US Nationwide distribution.
Lote
85OHM 1) REF CDS820075V, UDI/DI 10193489846973 (each) 40193489846974 (case), Lot Numbers: 22GBP851; 2) REF CDS820075W, UDI/DI 10195327209797 (each) 40195327209798 (case), Lot Numbers: 22HBH009, 23ABB066, 22JBX603, 22JBX483, 23ABM869, 22LBB096, 23EBB528, 23FBH057; 3) REF CDS980774M, UDI/DI 10193489383713 (each) 40193489383714 (case), Lot Numbers: 22JBT027, 23ABE914, 22KBE813, 23ABR052, 23GBL705, 24ABK006, 23JBQ162, 23LBT739, 23LBT825; 4) REF CDS981322AB, UDI/DI 10193489929997 (each) 40193489929998 (case), Lot Numbers: 22DBS923, 23EBE751, 23BBE438, 23HBS136; 5) REF CDS981322AC, UDI/DI 10195327539481 (each) 40195327539482 (case), Lot Numbers: 23LBJ448, 23LBJ388, 24BBF433, 24DMH817; 6) REF CDS982398I, UDI/DI 10195327029449 (each) 40195327029440 (case), Lot Numbers: 22HBF545, 22IBC664, 22JBL415, 22LBH995, 23BBS835, 23LBA643, 23JBV944, 23IBE632, 23HBJ717, 23EBP485, 24ABO332, 23FBS672, 24BBK936, 24EBC031, 24DBD943, 24CBU322, 24GBD705; 7) REF CDS983450L, UDI/DI 10193489372335 (each) 40193489372336 (case), Lot Numbers: 23ABF826, 23BBG537, 22FBS278, 22KBE444, 23JBR792; 8) REF CDS983869J, UDI/DI 10195327457617 (each) 40195327457618 (case), Lot Numbers: 23HDA541; 9) REF CDS984261J, UDI/DI 10195327139629 (each) 40195327139620 (case), Lot Numbers: 22IBF149, 23EBG169, 23CBE760, 22LBJ360, 22KBS546, 22KBS547; 10) REF CDS984516L, UDI/DI 10195327338626 (each) 40195327338627 (case), Lot Numbers: 23FDA887, 23HDB446, 23LDA038, 23JDB032, 23IDB803, 24ADA525, 23LDB093; 11) REF CDS984516M, UDI/DI 10195327629847 (each) 40195327629848 (case), Lot Numbers: 24BDB731, 24BDA997; 12) REF CDS984902K, UDI/DI 10195327156923 (each) 40195327156924 (case), Lot Numbers: 22LBH577, 23KBB878, 23HBU537, 23ABM570, 24ABI595, 24ABD063; 13) REF CDS984902L, UDI/DI 10195327584955 (each) 40195327584956 (case), Lot Numbers: 24DBI303; 14) REF CDS985282F, UDI/DI 10193489645606 (each) 40193489645607 (case), Lot Numbers: 22GBE278, 22FBL413, 22JBU598, 23DBL267, 23CBR985, 23BBN513, 23BBN776, 22KBR845, 23FBD738; 15) REF CDS985326G, UDI/DI 10195327091170 (each) 40195327091171 (case), Lot Numbers: 22GBJ024, 22GBF342, 22GBT686, 22FBR937, 23DBB697, 23ABJ487, 23JBU241; 16) REF CDS985505G, UDI/DI 10195327412555 (each) 40195327412556 (case), Lot Numbers: 23HBK247, 23GBD611, 23JBN811, 23JBN997; 17) REF CDSCCR611Q, UDI/DI 10195327398668 (each) 40195327398669 (case), Lot Numbers: 23GBU646, 23IBG367, 23KBJ756, 23JBS637; 18) REF DYNJ0100978K, UDI/DI 10195327339005 (each) 40195327339006 (case), Lot Numbers: 23GDB484, 23DDA636; 19) REF DYNJ0101147G, UDI/DI 10195327059880 (each) 40195327059881 (case), Lot Numbers: 22JMF390, 22LMD489, 23BMA081, 23GMI901, 23HMH876, 23JMI277, 23JMH328; 20) REF DYNJ0101562I, UDI/DI 10193489961935 (each) 40193489961936 (case), Lot Numbers: 22GDA866, 22FDA774; 21) REF DYNJ0101562K, UDI/DI 10195327351120 (each) 40195327351121 (case), Lot Numbers: 23GDB485; 22) REF DYNJ0101616L, UDI/DI 10195327339357 (each) 40195327339358 (case), Lot Numbers: 23CDA045, 23HDB479; 23) REF DYNJ0173422AF, UDI/DI 10195327097578 (each) 40195327097579 (case), Lot Numbers: 22GMA837, 22EMD852; 24) REF DYNJ0173422AG, UDI/DI 10195327308872 (each) 40195327308873 (case), Lot Numbers: 23GMD128, 23CME302, 23BMC001, 23KMD310, 23JMG171, 23IMH940; 25) REF DYNJ0190625Q, UDI/DI 10193489442595 (each) 40193489442596 (case), Lot Numbers: 22HME285, 22EMH998, 22KMF633, 22GMA165, 23EMG450, 23HMD259, 24BMC716, 23JMF345, 23JMA122, 23GMC332, 23FMA882, 23AMF892, 23AMH766, 23EMD161, 24AMI109, 24CMG231; 26) REF DYNJ02577D, UDI/DI 10193489958003 (each) 40193489958004 (case), Lot Numbers: 22HDB948, 22EDB860, 23BDB332, 22KDB125; 27) REF DYNJ02748F, UDI/DI 10193489990515 (each) 40193489990516 (case), Lot Numbers: 22IBQ419, 22CBA218, 22EBT508, 22DBB815, 22LBT229; 28) REF DYNJ0282506N, UDI/DI 10195327376031 (each) 40195327376032 (case), Lot Numbers: 23HBA336, 23EBO853, 23FBQ455, 23IBM182, 23GBN258; 29) REF DYNJ0366291O, UDI/DI 10195327484606 (each) 40195327484607 (case), L
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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