FDAFDA · Food and drugs·Recall number Z-1133-2024
Centurion Kits, trays, and packs labeled as follows: LATEX FREE TRACHEOSTOMY CARE TRAY, REF TC7170
Published March 6, 2024 · Recall initiated: November 15, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
- Lot
- REF TC7170, UDI/DI 50653160043629 (case), 00653160043624 (unit), Lot Numbers: 2022042790, 2022121290, 2023031790, 2023042490; 2023092190
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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