FDAFDA · Alimentos y medicamentos·N.º oficial Z-1122-2024
Medline Kits, trays, and packs labeled as follows: a) L&B CDS-LF, REF CDS980273D; b) LABOR AND DELIVERY, REF DYNJ907794; c) LACERATION TRAY, REF DYNDL1864A; d) OBSTETRICAL, REF DYNJ908877; e) UMC EP VAGINAL DELIVERY, REF DYNJ83093;
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 CDS980273D, UDI/DI 40884389851808 (case), 10884389851807 (unit), Lot Numbers: 22DBJ834; b) REF DYNJ907794, UDI/DI 40193489884952 (case), 10193489884951 (unit), Lot Numbers: 22BBB085, 22CBW699, 22FBH326, 22KBJ007, 22KBW578, 23ABL612, 23CBT573, 23HBD177; c) REF DYNDL1864A, UDI/DI 40889942721420 (case), 10889942721429 (unit), Lot Numbers: 22FBN858, 22IBN393, 23ABJ223, 23EBK530, 23HBS351; d) REF DYNJ908877, UDI/DI 40195327201747 (case), 10195327201746 (unit), Lot Numbers: 22HBT779, 22KBH144, 22LBM695, 23ABD156; e) REF DYNJ83093, UDI/DI 40195327230870 (case), 10195327230869 (unit), Lot Numbers: 22JME508, 23CMH924, 23DMH299, 23EMC295, 23FMB041
- Clasificación de riesgo
- Class I
- Área (FDA)
- device
- País
- United States
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