Volver al buscador
FDAFDA · Alimentos y medicamentos·N.º oficial Z-1101-2024

MEDLINE Kits, trays, and packs labeled as follows: a) ASC MINOR THYROID CDS, REF CDS983682F; b) BRONCHOSCOPY KIT, REF DYKE1718A; c) BRONCHOSCOPY KIT, REF DYKE1718B; d) DOUBLE CENTRAL LINE CAP CHANGE, REF DYNDC2214G; e) ENT PACK, REF DYNJ55334C; f) ENT PACK, REF DYNJ45175B; g) ENT PACK, REF DYNJ59030A; h) ENT PACK, REF DYNJ83416; i) ENT/EPISTAXIS TRAY, REF MNS2895; j) ENT/EPISTAXIS TRAY, REF MNS2895H; k) HEAD & NECK PACK, REF DYNJ60166C; l) HEAD AND NECK CDS, REF CDS983910K; m) HEAD AND NECK PACK, REF DYNJ68872C; n) HEAD AND NECK PACK, REF DYNJ46216J; o) NASAL, REF CDS984899G; p) NASAL, REF CDS984899I; q) PACK,BRONCHOSCOPY, REF DYNJ65475A; r) SINGLE CENTRAL LINE CAP CHANGE, REF DYNDC2213F; s) T & A, REF CDS984895I; t) T AND A, REF DYNJ36719C; u) T AND A, REF DYNJ906741B; v) T AND A CDS, REF CDS983362C; w) T&A PACK, REF DYNJ33112I; x) TONSIL CDS-LF, REF CDS980272L; y) TRACH CARE KIT, REF DYNDJN001A

Publicado el 6 de marzo de 2024 · Inicio del retiro: 15 de noviembre de 2023

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 Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
MEDLINE INDUSTRIES, LP - Northfield
Distribuidor
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Lote
a) REF CDS983682F; UDI/DI 40193489852975 (case), 10193489852974 (unit), lot Numbers: 22DDA235, 22GBJ113, 23ABQ437, 23EBS939; b) REF DYKE1718A; UDI/DI 40193489494656 (case), 10193489494655 (unit), Lot Numbers: 22FBU098, 22HBM601, 23ABM389; c) REF DYKE1718B; UDI/DI 40195327240128 (case), 10195327240127 (unit), Lot Numbers: 23DBE977; d) REF DYNDC2214G; UDI/DI 40195327051984 (case), 10195327051983 (unit), Lot Numbers: 22ABP471, 22BBO794, 22OBJ991; e) REF DYNJ55334C; UDI/DI 40889942703211 (case), 10889942703210 (unit), Lot Numbers: 22ABL051, 22EBV190, 22FBS394, 23BBA777, 23GBL169; f) REF DYNJ45175B; UDI/DI 40889942485216 (case), 10889942485215 (unit), Lot Numbers: 22CLB148, 22GLB002; g) REF DYNJ59030A; UDI/DI 40195327026203 (cases), 10195327026202 (unit), Lot Numbers: 22DBR838, 22EBO071, 22JBW765, 23FBF261, 23GBC456, 23HBR618; h) REF DYNJ83416; UDI/DI 40195327265053 (cases), 10195327265052 (unit), Lot Numbers: 22LBF471, 23ABN102, 23BBA471; i) REF MNS2895; UDI/DI 50653160062934 (case), 653160062939 (unit), Lot Numbers: 23BBQ180, 23DBN766, 23EBH195, 23FBE540; j) REF MNS2895H; UDI/DI 50653160062934 (case), 653160062939 (unit), Lot Numbers: 23BBQ180, 23DBN766, 23EBH195, 23FBE540; k) REF DYNJ60166C; UDI/DI 40193489467148 (case), 10193489467147 (unit), Lot Numbers: 23ELB099; l) REF CDS983910K; UDI/DI 40195327256594 (case), 10195327256593 (unit), Lot Numbers: 22JBT244, 23ABP271, 23ABP272, 23ABQ792, 23CBE912, 23DBR779, 23FBB371, 23JBL006, 23JBR337; m) REF DYNJ68872C; UDI/DI 40195327375714 (case), 10195327375713 (unit), Lot Numbers: 23DBC646, 23FBA039, 23GBA604, 23HBZ389, 23JBN556; n) REF DYNJ46216J; UDI/DI 40195327407491 (case), 10195327407490 (unit), Lot Numbers: 23EBF873, 23GBO919, 23GBT576, 23IBE145; o) REF CDS984899G; UDI/DI 40193489983822 (case), 10193489983821 (unit), Lot Numbers: 22CLA789; p) REF CDS984899I; UDI/DI 40195327313297 (case), 10195327313296 (unit), Lot Numbers: 23IBV180; q) REF DYNJ65475A; UDI/DI 40193489974578 (case), 10193489974577 (unit), Lot Numbers: 22DBF905; r) REF DYNDC2213F; UDI/DI 40195327052080 (case), 10195327052089 (unit), Lot number: 22ABM936, 22CMG684, 22EMB991; s) REF CDS984895I; UDI/DI 40193489983815 (case), 10193489983814 (unit), Lot Number: 22FBL382, 22IBD790, 23ABM451, 23DBM334; t) REF DYNJ36719C; UDI/DI 40193489265539 (case), 10193489265538 (unit), Lot Numbers: 21LBA818, 21LBU235, 22BBL912; u) REF DYNJ906741B; UDI/DI 40195327055364 (case), 10195327055363 (unit), Lot Numbers: 22ABF704, 22ABL214, 22BBQ966, 22FBY564, 22GBQ902, 22HMI302, 23AMA387, 23AMI317; v) REF CDS983362C; UDI/DI 40193489267342 (case), 10193489267341 (unit), Lot Numbers: 23ABI733; w) REF DYNJ33112I; UDI/DI 40193489402736 (case), 10193489402735 (unit), Lot Numbers: 22DBO140, 22DBO155, 22JBY668, 23BBT134, 23DBT051, 23EBA549, 23HBI328, 23IBM005; x) REF CDS980272L; UDI/DI 40193489616331 (case), 10193489616330 (unit), Lot Numbers: 22NBC732; y) REF DYNDJN001A; UDI/DI 40193489421614 (case), 10193489421613 (unit), Lot Numbers: 22EBB217, 22FBQ070, 22FBU496
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

¿Vendes productos como este?

Recalert vigila todo tu catálogo contra retiros como este, automáticamente.

Empezar gratis — sin tarjeta