Medical device recalls High risk

MEDLINE INDUSTRIES, LP - Northfield recalls Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT,…

Recall date
February 24, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1505-2025
FDA classification
Class I
Brand / firm
MEDLINE INDUSTRIES, LP - Northfield
Sold / distributed
California

Why it was recalled

Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were subsequently recalled by Smiths Medical.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT, REF ACC010381A; 3) NEWBORN RESUSCITATION KIT, REF ACC010381B; 4) NEWBORN RESUSCITATION KIT, REF ACC010381C; 5) PEDS GREY-PINK-RED, REF ACC010395; 6) PEDS PURPLE, REF ACC010397; 7) NEONATAL INTUBATION TRAY, REF ACC010541A; 8) NEONATAL INTUBATION TRAY, REF ACC010541B; 9) NEONATAL INTUBATION TRAY, REF ACC010541C; 10) PEDIATRICS INTUBATION TRAY, REF DYNJAA252.

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