FDAFDA · Alimentos y medicamentos·N.º oficial Z-0155-2025
Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOGY LP TRAY, REF DYNDH1609; b) CARDIAC CATH PACK-LF, REF DYNJ19010I; c) SUPPLEMENTAL NEURO ANGIO PK, REF DYNJ29207; d) ANGIO PACK, REF DYNJ43661C; e) LEFT HEART CATH TEGH-LF, REF DYNJ46746C; f) LFT HRT CATH RADIAL ACCESS-LF, REF DYNJ47667C; g) IR ARM PACK, REF DYNJ50712D; h) IR PACK, REF DYNJ67324; i) PL. CATHETERISME CARDIAQUE, REF HCT093J
Publicado el 30 de octubre de 2024 · Inicio del retiro: 4 de septiembre 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
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
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 - US Nationwide and the countries of Canada, Panama.
- Lote
- a) REF DYNDH1609: UDI/DI 40193489844802 (each), 10193489844801 (case), Lot Numbers: 23LBO852; b) REF DYNJ19010I: UDI/DI 40888277858627 (each), 10888277858626 (case), Lot Numbers: 23LBK443; c) REF DYNJ29207: UDI/DI 40080196015413 (each), 10080196015412 (case), Lot Numbers: 23LBL962; d) REF DYNJ43661C: UDI/DI 40195327104353 (each), 10195327104351 (case), Lot Numbers: 23LBU931; e) REF DYNJ46746C: UDI/DI 40195327040162 (each), 10195327040161 (case), Lot Numbers: 23LBK374; f) REF DYNJ47667C: UDI/DI 40195327040179 (each), 10195327040178 (case), Lot Numbers: 23LBL629; g) REF DYNJ50712D: UDI/DI 40195327267927 (each), 10195327267926 (case), Lot Numbers: 23KBE846; h) REF DYNJ67324: UDI/DI 40193489395625 (each), 10193489395624 (case), Lot Numbers: 23LBL780; i) REF HCT093J: UDI/DI 40884389905679 (each), 10884389905678 (case), Lot Numbers: 23LBG513
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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