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FDAFDA · Food and drugs·Recall number Z-1121-2024

Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B; b) NUR 213, REF EDUC05054B; c) NURSING SKILLS, REF EDUC05050B; d) NURSING SUPPLY BAG, REF EDUC1024

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 EDUC05053B, UDI/DI 40195327152759 (case), 10195327152758 (unit), Lot Numbers: 22HDA208; b) REF EDUC05054B, UDI/DI 40195327152766 (case), 10195327152765 (unit), Lot Numbers: 22FDA648, 22GDA631; c) REF EDUC05050B, UDI/DI 40195327166749 (case), 10195327166748 (unit), Lot Numbers: 22HLA620, 22HLB059, 22ILA209, 22ILA210, 22KLA131, 22LLA961, 23GLA207, 23GLA933, 23GLB218, 23HLB203; d) REF EDUC1024, UDI/DI 40195327493166 (case), 10195327493165 (unit), Lot Numbers: 23CDB444, 23EDB632, 23GDA553, 23GDB595, 23HDA559, 23IDA904, 23JDA398
Risk classification
Class I
Area (FDA)
device
Country
United States

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