PlainRecalls
FDA Devices Critical Class I Ongoing

MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511

Reported: March 6, 2024 Initiated: November 15, 2023 #Z-1090-2024

Product Description

MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511

Reason for Recall

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.

Details

Units Affected
385028 trays
Distribution
Distribution US nationwide including Puerto Rico, Canada, UAE, and Panama
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 385028 trays.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 6, 2024. Severity: Critical. Recall number: Z-1090-2024.