FDA Device recall Z-2514-2023
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
- FDA Device
- Class I
- ongoing
- Published 2023-09-20
On 2023-09-20 the FDA classified a Class I recall of HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U by Medline Industries Northfield, citing product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2514-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-08-04 |
| Published | 2023-09-20 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
Reason
Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
Identifiers
| code_info | UDI/DI 140267047147818, Lot code 3B085 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2514-2023%22
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