FDAFDA · Alimentos y medicamentos·N.º oficial Z-3024-2024
Medline Convenience kits labeled as: 1) PREP TRAY, Pack Number DYNDA1540; 2) STERILE PREP TRAY , Pack Number DYNDA2499; 3) ED PREP TRAY, Pack Number DYNDA2519; 4) ED PREP TRAY, Pack Number DYNDA2519H ; 5) PRE-OP PREP KIT , Pack Number DYNDA3076; 6) PILGRIM PREP TRAY , Pack Number DYNDC3282; 7) PILGRIM PREP TRAY , Pack Number DYNDC3282A ; 8) PILGRIM PREP TRAY , Pack Number DYNDC3282B ; 9) KYPHO PREP PACK-LF, Pack Number DYNJ0618280G ; 10) KYPHO PREP PACK-LF, Pack Number DYNJ0618280I ; 11) KYPHO PREP PACK-LF, Pack Number DYNJ0618280J ; 12) SPECIAL PROCEDURE PREP TRAY-LF, Pack Number DYNJ0738967A ; 13) BASIC SET UP PACK-LF, Pack Number DYNJ28988I ; 14) BASIC SET UP PACK-LF , Pack Number DYNJ28988I ; 15) VERTEBRALPLASTY PREP TRAY PACK, Pack Number DYNJ36311A ; 16) PK-SETUP PACK , Pack Number DYNJ43804A ; 17) SKIN LESION PACK, Pack Number DYNJ44258G ; 18) SETUP PACK, Pack Number DYNJ46187D ; 19) PK-SET UP -LF , Pack Number DYNJ53220B ; 20) IR PATIENT PREP KIT-LF, Pack Number DYNJ64857A ; 21) SKIN SCRUB PACK , Pack Number DYNJ68561; 22) DMEK PREP PACK, Pack Number DYNJ81659A ; 23) SET UP PACK , Pack Number DYNJ84247; 24) BASIC SET UP PACK-LF, Pack Number DYNJ85036; 25) SET UP CDS-ASC, Pack Number DYNJ900073C; 26) GENERAL SET UP, Pack Number DYNJ906282C; 27) JEWISH MAJOR SETUP, Pack Number DYNJ909261A; 28) SET UP, Pack Number DYNJ909403 ; 29) PREP TRAY , Pack Number DYNJRA1280A; 30) PREP TRAY , Pack Number DYNJRA1424 ; 31) NERVE BLOCK/W , Pack Number DYNJRA1424H; 32) PREP TRAY, Pack Number DYNJRA1498B; 33) PREP TRAY , Pack Number DYNJRA1583C; 34) PREP TRAY , Pack Number DYNJRA1760 ; 35) PREP TRAY , Pack Number DYNJRA1774 ; 36) PREP TRAY , Pack Number DYNJRA1783 ; 37) PREP TRAY , Pack Number DYNJRA1946A; 38) WINCHESTER PREP PACK-LF , Pack Number PHS627837003 ; 39) WINCHESTER PREP PACK-LF , Pack Number PHS627837003A
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
- DYNDA1540, Lot Number 23JBV995; DYNDA1540, Lot Number 23GBA155; DYNDA1540, Lot Number 23EBB508; DYNDA1540, Lot Number 22LBK096; DYNDA1540, Lot Number 22JBQ748; DYNDA1540, Lot Number 22HBC421; DYNDA1540, Lot Number 22DBP691; DYNDA1540, Lot Number 22ABU584; DYNDA1540, Lot Number 21BBI623; DYNDA1540, Lot Number 20LBU589; DYNDA1540, Lot Number 20KBL865; DYNDA1540, Lot Number 20JBP526; DYNDA1540, Lot Number 20IBD073; DYNDA1540, Lot Number 20HBT535; DYNDA1540, Lot Number 20HBQ630; DYNDA1540, Lot Number 20HBB154; DYNDA1540, Lot Number 2019050290; DYNDA1540, Lot Number 2019061890; DYNDA1540, Lot Number 2019071290; DYNDA2499, Lot Number 21JBI254 ; DYNDA2519, Lot Number 22FBC352 ; DYNDA2519H , Lot Number 22FBC352 ; DYNDA3076, Lot Number 24ABU746 ; DYNDC3282, Lot Number 23CLA266 ; DYNDC3282, Lot Number 23DLA289 ; DYNDC3282, Lot Number 23FLA594 ; DYNDC3282A , Lot Number 23HLA208 ; DYNDC3282A , Lot Number 23ILA470 ; DYNDC3282B , Lot Number 23LLA874 ; DYNDC3282B , Lot Number 24CLA486 ; DYNJ0618280G , Lot Number 19BBA500 ; DYNJ0618280G , Lot Number 19BBK048 ; DYNJ0618280I , Lot Number 21HBF705 ; DYNJ0618280I , Lot Number 22EBJ300 ; DYNJ0618280I , Lot Number 19PBC248 ; DYNJ0618280I , Lot Number 19HBJ382 ; DYNJ0618280I , Lot Number 20BBX426 ; DYNJ0618280I , Lot Number 20DBN589 ; DYNJ0618280I , Lot Number 20EBF905 ; DYNJ0618280I , Lot Number 20IBA358 ; DYNJ0618280I , Lot Number 20IBJ312 ; DYNJ0618280I , Lot Number 20JBO345 ; DYNJ0618280J , Lot Number 22LBE471 ; DYNJ0618280J , Lot Number 23GBW260 ; DYNJ0618280J , Lot Number 23KBE106 ; DYNJ0738967A , Lot Number 19ABK292 ; DYNJ0738967A , Lot Number 19ABS637 ; DYNJ0738967A , Lot Number 19BBC096 ; DYNJ0738967A , Lot Number 19FBG026 ; DYNJ0738967A , Lot Number 19GBT425 ; DYNJ0738967A , Lot Number 19IBM307 ; DYNJ0738967A , Lot Number 19KBP191 ; DYNJ0738967A , Lot Number 20ABR041 ; DYNJ0738967A , Lot Number 20BBP817 ; DYNJ0738967A , Lot Number 20CBU110 ; DYNJ0738967A , Lot Number 20DBV286 ; DYNJ0738967A , Lot Number 20EBF979 ; DYNJ0738967A , Lot Number 20EBL088 ; DYNJ0738967A , Lot Number 20FBH972 ; DYNJ0738967A , Lot Number 20HBJ232 ; DYNJ28988I , Lot Number 23FLA367 ; DYNJ28988I , Lot Number 23GLA394 ; DYNJ28988I , Lot Number 23GLB068 ; DYNJ28988I , Lot Number 23HLA778 ; DYNJ28988I , Lot Number 23JLA349 ; DYNJ28988I , Lot Number 23JLB091 ; DYNJ28988I , Lot Number 23LLA861 ; DYNJ28988I , Lot Number 24BLA093 ; DYNJ28988I , Lot Number 23LLA359 ; DYNJ28988I , Lot Number 24CLA351 ; DYNJ36311A , Lot Number 19BKC718 ; DYNJ36311A , Lot Number 19CKC109 ; DYNJ43804A , Lot Number 23ABS693 ; DYNJ43804A , Lot Number 23DBJ631 ; DYNJ43804A , Lot Number 23GBS752 ; DYNJ43804A , Lot Number 23HBR871 ; DYNJ43804A , Lot Number 23KBE834 ; DYNJ43804A , Lot Number 23LBL776 ; DYNJ44258G , Lot Number 21ADB154 ; DYNJ46187D , Lot Number 23IMH258 ; DYNJ46187D , Lot Number 23LMD118 ; DYNJ53220B , Lot Number 22LMF612 ; DYNJ53220B , Lot Number 23BMH755 ; DYNJ53220B , Lot Number 23DMB617 ; DYNJ53220B , Lot Number 23EME353 ; DYNJ53220B , Lot Number 23FMC893 ; DYNJ53220B , Lot Number 23FMJ703 ; DYNJ53220B , Lot Number 23IMH249 ; DYNJ53220B , Lot Number 23KMA406 ; DYNJ53220B , Lot Number 24AMC542 ; DYNJ64857A , Lot Number 23GMB325 ; DYNJ68561, Lot Number 21GBT186 ; DYNJ68561, Lot Number 21HBN324 ; DYNJ68561, Lot Number 21IBF299 ; DYNJ68561, Lot Number 21JBU945 ; DYNJ68561, Lot Number 21KBR048 ; DYNJ68561, Lot Number 22ABE326 ; DYNJ68561, Lot Number 22CBZ837 ; DYNJ68561, Lot Number 22EBR300 ; DYNJ68561, Lot Number 22GBR532 ; DYNJ68561, Lot Number 22IBA354 ; DYNJ68561, Lot Number 22KBA954 ; DYNJ68561, Lot Number 23BBD411 ; DYNJ68561, Lot Number 23CBR350 ; DYNJ68561, Lot Number 23DBJ393 ; DYNJ68561, Lot Number 23EBJ138 ; DYNJ68561, Lot Number 23FBI706 ; DYNJ68561, Lot Number 23GBK621 ; DYNJ68561, Lot Number 23IBL911 ; DYNJ68561, Lot Number 23KBJ288 ; DYNJ68561, Lot Number 23LBN184 ; DYNJ68561, Lot Number 21CBA125 ; DYNJ68561, Lo
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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