FDAClass IMarch 6, 2024

Medline Tray Trach Basic Solution recall: Sterility Concern

MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511

Why was Medline Tray Trach Basic Solution recalled?

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 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?

UDI/DI 40888277597922 (case), 10888277597921 (unit), Lot Numbers: 22DBO136, 22EBE146, 22HBP422, 22IBN508, 22IBS920, 22KBS241, 23BBE594, 23CBN979, 23EBT594, 23IBA884

Product
MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
385028 trays
Distribution
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Recall date
March 6, 2024
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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