FDAFDA · Food and drugs·Recall number 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
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
- 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
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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