HUDSON RCI Addipak — Class I medical device recall Z-2514-2023
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2023-09-20, distributed nationwide. Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customer
| Recall number | Z-2514-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2023-08-04 |
| Classified | 2023-09-14 |
| Reported by FDA | 2023-09-20 |
| Distributed | Nationwide (US) |
| Quantity | 18,000 units |
| Reason classes | sterility |
| Lot numbers | 3B085 |
| Model numbers | RHUD59U |
Product
HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
Reason for recall
Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2514-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.