FDAFDA · Alimentos y medicamentos·N.º oficial Z-1121-2024
Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B; b) NUR 213, REF EDUC05054B; c) NURSING SKILLS, REF EDUC05050B; d) NURSING SUPPLY BAG, REF EDUC1024
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 EDUC05053B, UDI/DI 40195327152759 (case), 10195327152758 (unit), Lot Numbers: 22HDA208; b) REF EDUC05054B, UDI/DI 40195327152766 (case), 10195327152765 (unit), Lot Numbers: 22FDA648, 22GDA631; c) REF EDUC05050B, UDI/DI 40195327166749 (case), 10195327166748 (unit), Lot Numbers: 22HLA620, 22HLB059, 22ILA209, 22ILA210, 22KLA131, 22LLA961, 23GLA207, 23GLA933, 23GLB218, 23HLB203; d) REF EDUC1024, UDI/DI 40195327493166 (case), 10195327493165 (unit), Lot Numbers: 23CDB444, 23EDB632, 23GDA553, 23GDB595, 23HDA559, 23IDA904, 23JDA398
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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