FDAFDA · Alimentos y medicamentos·N.º oficial Z-1134-2024
Centurion Kits, trays, and packs labeled as follows: a) IV SECUREMENT KIT, REF IVS1860B; b) NEONATAL PICC LINE INSERTION TRAY, REF CVI2025; c) NEONATAL PICC LINE INSERTION TRAY, REF CVI4570; d) SECONDARY IV START KIT, REF IV8695A
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 IVS1860B, UDI/DI 00653160351354 (case), 10653160351351 (unit), Lot Numbers: 2022041880, 2022082280; b) REF CVI2025, UDI/DI 50653160060459 (case), 00653160060454 (unit), Lot Numbers: 2022053190; c) REF CVI4570, UDI/DI 00653160323382 (case), 10653160323389 (unit), Lot Numbers: 2022042690, 2022072590, 2022103190, 2023041290, 2023051090; d) REF IV8695A, UDI/DI 00653160348569 (case), 10653160348566 (unit), Lot Numbers: 2021121750, 2022030780
- 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.