FDAFDA · Alimentos y medicamentos·N.º oficial Z-1092-2024
MEDLINE kits and trays, labeled as: a) SUCTION CATH 10FR KIT W/SALINE, REF DYND41470SA, DYND41470SAH; b) TRACH CARE TRAY, REF DYNDA1931B, DYNDA1931BH
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 DYND41470SA, UDI/DI 40884389338705 (case), 10884389338704 (unit), Lot Numbers: 22HBD360, 22IBA256, 23ABU349, 23CBG160, 23GBV051, 23IBT355; REF DYND41470SAH; UDI/DI - same as DYND41470SA, Lot Numbers: 22HBD360, 22IBA256, 23ABU349, 23CBG160, 23GBV051, 23IBT355; b) REF DYNDA1931B, UDI/DI 40195327277360 (case), 10195327277369 (unit), Lot Numbers: 22LMC118, 22LMC126, 23EMB086; REF DYNDA1931BH, UDI/DI - same as DYNDA1931B, Lot Numbers: 22LMC118, 22LMC126, 23EMB086
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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