FDA Device recall Z-1121-2024
Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B
- FDA Device
- Class I
- ongoing
- Published 2024-03-06
On 2024-03-06 the FDA classified a Class I recall of Medline Kits, trays, and packs labeled as follows: a) NUR 105, REF EDUC05053B by Medline Industries Northfield, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1121-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-11-15 |
| Published | 2024-03-06 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
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
Reason
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.
Identifiers
| code_info | a) REF EDUC05053B, UDI/DI 40195327152759 (case), 10195327152758 (unit), Lot Numbers: 22HDA208; b) REF EDUC05054B, UD…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 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1121-2024%22
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