FDAClass IApril 16, 2025

Medline medical convenience kits labeled as: 1) recall

Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT, REF ACC010381A; 3) NEWBORN…

Why was Medline medical convenience kits labeled as: 1) recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

1) REF ACC010371C: UDI/DI 10193489268188 (ea) 40193489268189 (case), Lot Numbers: 20DDA921, 20EDC042, 20IDC153, 21ADB113, 21CDB435, 21HDB557, 21JDA180, 21LDB244, 22HDB092, 22IDA205, 22JDA908, 22KDA049, 22LDA351, 23EDC611; 2) REF ACC010381A: UDI/DI 10193489800944 (ea) 40193489800945 (case), Lot Numbers: 20BDB854, 20FDA703; 3) REF ACC010381B: UDI/DI 10193489457803 (ea) 401934894578049 (case), Lot Numbers: 20LDA314, 20LDA466, 21ADB162, 21BDB508; 4) REF ACC010381C: UDI/DI 10193489922127 (ea) 40193489922128 (case), Lot Numbers: 21IDA608, 21JDB271, 21KDA979, 21LDA450, 22BDA818, 22FDB822, 22KDB696, 23ADA938, 23CDA005, 23CDB015, 23EDA977, 23FDB762, 23IDB196, 23LDA440, 23LDB579, 24CDA637, 24GDB084, 24IDB423, 24JDB726, 24KDB730; 5) REF ACC010395: UDI/DI 10193489218152 (ea) 40193489218153 (case), Lot Numbers: 20BDC901; 6) REF ACC010397: UDI/DI 10193489218169 (ea) 40193489218160 (case), Lot Numbers: 20CDA453, 20CDA459, 20EDB330; 7) REF ACC010541A: UDI/DI 10195327036980 (ea) 40195327036981 (case), Lot Numbers: 22ADA311; 8) REF ACC010541B: UDI/DI 10195327153649 (ea) 40195327153640 (case), Lot Numbers: 22EDB187; 9) REF ACC010541C: UDI/DI 10198459155765 (ea) 40198459155766 (case), Lot Numbers: 24JDC035; 10) REF DYNJAA252: UDI/DI 10193489297980 (ea) 40193489297981 (case), Lot Numbers: 20EBC867, 20EBD635, 20FBJ920, 22FBF130, 22IBP405

Product
Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, REF ACC010371C; 2) NEWBORN RESUSCITATION KIT, REF ACC010381A; 3) NEWBORN…
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
1550 units
Distribution
California
Recall date
April 16, 2025
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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