Medline Fluid Delivery Set with Drip Chamber: 1) FDS — Class I medical device recall Z-0764-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-01-22, distributed nationwide. Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey mi
| Recall number | Z-0764-2025 |
|---|---|
| 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 | 2024-12-16 |
| Classified | 2025-01-15 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| Quantity | 13,600 units |
| UPC / GTIN / UDI-DI | 10193489069587, 10197344018543, 10197344018550, 10197344018567, 10197344018642, 30193489069581, 30197344018547, 30197344018554, 30197344018561, 30197344018646 |
| Lot numbers | 0000128741, 0000133018, 0000133031, 0000133036, 0000133893, 0000134505, 0000135769, 0000136573, 0000139596 |
| Model numbers | 949000221, 949000222, 949000223, 949000224, 99000069 |
Product
Medline Fluid Delivery Set with Drip Chamber: 1) FDS,135,CHMN,W/F,MLL,RC(2),PG, Item Number 99000069; 2) FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, Item Number 949000222; 3) FDS,135,NV,MICRO-CHAMBER,W/FILTER,GREEN, Item Number 949000224; 4) FDS,135,NV,MICRO-CHAMBER,W/FILTER,RED, Item Number 949000221; 5) FDS,135,NV,MICRO-CHAMBER,W/FILTER,YELLOW, Item Number 949000223
Reason for recall
Fluid Delivery Sets were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. The macro drip chamber delivers three times more fluid per drop than the micro drip chamber.
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-0764-2025. 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.