FDAFDA · Alimentos y medicamentos·N.º oficial Z-1936-2024
Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW PR, Item Number: DYNJSYRPP20B; c) SYRINGE 20ML RED L/L LOW PRESS, Item Number: DYNJSYRPP20R; d) SYRINGE 10ML RED L/L LOW PR, Item Number: DYNJSYRPP10R; e) SYRINGE 10ML GREEN L/L LOW PR, Item Number: DYNJSYRPP10G; f) SYRINGE 10ML WHITE L/L LOW PR, Item Number: DYNJSYRPP10W; g) SYRINGE CNTRL 10ML RED L/L LP, Item Number: DYNJSYCPP10R; h) SYRINGE 5ML YELLOW L/L LOW PR, Item Number: DYNJSYRPP5Y; i) SYRINGE CNTRL 10ML YEL L/L LP, Item Number: DYNJSYCPP10Y; j) SYRINGE 3ML YELLOW L/L LOW PR, Item Number: DYNJSYRPP3Y; k) SYRINGE 5ML WHITE L/L LOW PR, Item Number: DYNJSYRPP5W; l) SYRINGE,CONTROL,LL,FINGER GRIPS,10ML, Item Number: DYNJPOLYCON1
Publicado el 12 de junio de 2024 · Inicio del retiro: 17 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
These syringes were identified to be 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 · Letter
Detalles del retiro
- Fabricante
- MEDLINE INDUSTRIES, LP - Northfield
- Distribuidor
- Worldwide distribution - US Nationwide and the countries of Canada, Panama.
- Lote
- a) Item Numbers: 1. DNSC91881, GTIN 10884389730225, Lot Numbers: 23KDA810, 23KDA809, 23KDA808, 23JDB372, 23JDB371, 23JDB370, 23FDB723, 23FDB722, 23FDB721, 23EDC604, 23EDC601, 23EDC598, 23DDA082, 23CDA063, 22LDB994, 22JDB444, 22JDB317, 22GDA044, 22CDB364, 22CDB363, 22BDB197, 22BDB107, 22ADC307, 22ADC306, 21KDB939, 21KDB938, 21KDB937, 21KDB854, 21KDB195, 21KDA579, 21KDA578, 21JDC617, 21JDC189, 21JDC188, 21JDC187, 21IDC072, 21IDC071, 21IDC070, 21GDA290, 21FDA195, 21FDA194, 21FDA193, 21EDB429, 21EDB114, 21DDC271, 21DDC270, 21DDC269, 20593, 21DDA598, 21DDA597, 21DDA596, 21DDA121, 21CDA858, 21CDA830, 21CDA816, 21BDA571, 21BDA566, 21BDA236, 21ADA763, 21ADA762, 21ADA761, 20KDB349, 20KDB348, 20KDB345, 20HDC716, 20HDC715, 20HDC714, 20FDB669, 20FDA588, 20FDA587, 20FDA578, 20DDB051, 20DDB050, 20DDB040, 20CDA310, 20BDC437, 20BDC430, 20BDB460, 19LDC885, 19JDB712, 19JDB707, 19JDB701, 19JDA632, 19IDB925, 19IDB160, 19IDB010, 19IDA604, 19HDA821, 8501-4, 19FDA536, 19EDD493, 19EDB908, 19EDB897, 19EDB002, 19DDB541, 19CDB785, 19CDA598, 19CDA587, 19BDB418, 19BDA447, 19ADB979, 19ADB382, 19ADA155; 2. DYNJSYRPPC10, GTIN 40884389854175, Lot Numbers: 21EBO376, 21EBO373, 21EBE760, 21EBE676, 19EBS670, 19PBB067, 19CBF350, 19ABI078, 21GBA704; b) Item Number: DYNJSYRPP20B, GTIN 40193489510615, Lot Numbers: 19DBF219; c) Item Number: DYNJSYRPP20R, GTIN 40193489510646, Lot Numbers: 19VBF198, 22KBI924, 22KBH332, 22JBN941, 22JBE021, 22DBO577, 22BBH657; d) Item Number: DYNJSYRPP10R, GTIN 40193489510677, Lot Numbers: 23JBQ600, 23HBB479, 23GBR483, 23EBC497, 23DBH387, 19VBF197, 22JBF882, 22OBC539, 22OBC538, 22OBA224, 22CBV052; e) Item Number: DYNJSYRPP10G, GTIN 40193489510684, Lot Numbers: 23HBW354; f) Item Number: DYNJSYRPP10W, GTIN 40193489510691, Lot Numbers: 24ABB058, 24ABB057, 24ABB056, 24ABB055, 24ABB054, 23KBL638, 23JBV978, 23FBP607, 23FBN611, 23FBD501, 23FBD500, 23EBW297, 23BBK362, 23BBG403, 23BBF237, 22JBJ540, 22JBE187, 22JBE023, 22OBD675, 22OBD674, 22OBA198, 22BBH572, 22ABZ717, 21LBD201, 21KBJ994; g) Item Number: DYNJSYCPP10R, GTIN 40193489510776, Lot Numbers: 22JBR164; h) Item Number: DYNJSYRPP5Y, GTIN 40193489511209, Lot Numbers: 23HBW356, 19VBF199; i) Item Number: DYNJSYCPP10Y, GTIN 40193489511216, Lot Numbers: 22JBR165; j) Item Number: DYNJSYRPP3Y, GTIN 40193489511377, Lot Numbers: 23HBW355; k) Item Number: DYNJSYRPP5W, GTIN 40193489510769, Lot Numbers: 23CBN165, 23CBA105, 23BBM437, 23BBE585, 23BBE124, 22LBN160, 22KBI921, 22KBH212, 22EBK611, 22OBM559, 21KBV178, 21KBP743, 21KBN796; l) Item Number: DYNJPOLYCON1,GTIN 10889942000500, Lot Numbers: 63719060006, 63719060007, 63719060007, 63719060007, 63719060007, 63719060007, 63719060007, 63719060007, 63719070006, 63719080005, 63719080005, 63719080005, 63719100007, 63719100007, 63719100007, 63719120006, 63721050003, 63721050003, 63721050003, 63721050003, 63721050003, 63721050003, 63721050003, 63721060003, 63721070005, 63721070008, 63721070008, 63721090007, 63721110005, 63721120005, 63722020001, 63722030005, 63722030005, 63722030005, 63722030005, 63722030005, 63722050004, 63722040008, 63722090008, 63722100001, 63722100005, 63722100006, 63722110002, 63722120005, 63722120006, 63722120006, 63723020005, 63724010001, 63724010001
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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