FDAFDA · Alimentos y medicamentos·N.º oficial Z-3034-2024
Medline Convenience kits labeled as: 1) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212; 2) PROCESSING KIT 3 PTE0000204 , Pack Number DYNJ65728A ; 3) 30ML KIT, Pack Number DYNJ82155A ; 4) DISSECTION, Pack Number DYNJ85191; 5) FLAP HARVEST PACK , Pack Number DYNJ58575C ; 6) KIT, MIDSTREAM, W/BZK/FUNNL,3O, Pack Number DYND30212H ; 7) FLAP HARVEST PACK, Pack Number DYNJ58575C
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
- DYND30212, Lot Number 20CBV412 ; DYND30212H , Lot Number 20CBV412 ; DYNJ58575C, Lot Number 22FMF260; DYNJ58575C, Lot Number 22EMI154; DYNJ58575C , Lot Number 22JMF580 ; DYNJ65728A , Lot Number 21IBJ821 ; DYNJ65728A , Lot Number 21IBV204 ; DYNJ65728A , Lot Number 21JBE157 ; DYNJ82155A , Lot Number 23CBD960 ; DYNJ82155A , Lot Number 23CBH024 ; DYNJ82155A , Lot Number 23DBL430 ; DYNJ82155A , Lot Number 23EBI493 ; DYNJ82155A , Lot Number 23FBO135 ; DYNJ82155A , Lot Number 23FBO795 ; DYNJ82155A , Lot Number 23GBJ181 ; DYNJ82155A , Lot Number 23HBJ559 ; DYNJ82155A , Lot Number 23IBJ041 ; DYNJ82155A , Lot Number 23IBJ042 ; DYNJ85191, Lot Number 23JBP679
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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