Medline Fluid Delivery Set with Drip Chamber: 1) MTO — Class I medical device recall Z-0765-2025
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-0765-2025 |
|---|---|
| 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 | 3,930 units |
| UPC / GTIN / UDI-DI | 10193489044928, 10193489045611, 10193489045864, 10193489046465, 10193489048292, 10193489049817, 10193489053326, 10193489057805, 10193489060904, 10193489061314, 10193489063950, 10193489070170, 10193489070224, 10193489070231, 10193489070989, 10193489071337, 10193489071344, 10193489071498, 10193489072754, 10193489072815, 10193489075458, 10193489099843, 20193489046462, 20193489060901, 20193489061311 and 20 more |
| Lot numbers | 0000127859, 0000127874, 0000128447, 0000128607, 0000128715, 0000128721, 0000128757, 0000129513, 0000129523, 0000129534, 0000129541, 0000129544, 0000130138, 0000130171, 0000130187, 0000130573, 0000130577, 0000130833, 0000130940, 0000130984, 0000130988, 0000131376, 0000131600, 0000131619, 0000131657, 0000131669, 0000131878, 0000131883, 0000132222, 0000132350, 0000132393, 0000133025, 0000133032, 0000133060, 0000133121, 0000133659, 0000133660, 0000134701, 0000134729, 0000134940 and 14 more |
| Model numbers | 600602914, 600604422, 600604423, 60100045, 6010771601, 60110552, 60120583, 601305210, 60130527, 601400110, 601400111, 601403920, 601403921, 60150035, 60182723, 602301614, 60232481, 602500214, 62140602, 65071193, 650801715, 65111341, 65232486 |
Product
Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Number: 60130527; 2) MTO,ANGIO,DOUBLE,SPIKE,KIT,KENNEDY HLTH, Item Number: 65111341; 3) MTO,ANGIO,SINGLE,SPIKE,KIT, Item Number: 65232486; 4) MTO,ANGIO,SINGLE,SPIKE,KIT,GOOD,SAM, Item Number: 65071193; 5) MTO,NEURO,FLUSH,SPIKE,KIT,BLUE,FLORIDA, Item Number: 600604422; 6) MTO,NEURO,KIT,-,JERSEY,SHORE PG, Item Number: 60100045; 7) MTO,RADIOLOGY,KIT,HAMOT MED CEN, Item Number: 650801715; 8) MTS,135,CDS,IV,TUBE-JEFFERSON UNIV., Item Number: 60232481; 9) MTS,135,YELLOW,MICRO,SPIKE,LUTHERAN MED, Item Number: 60120583; 10) MTS,ANGIO,NEURO,KIT,NORTH SHORE UNIV, Item Number: 601403920; 11) MTS,CUST. FILTER-NEWYORK UNIVERSITY, Item Number: 62140602; 12) MTS,INTERV,NEURO,KIT-WESTCHESTER,MC, Item Number: 602301614; 13) MTS,NEU,NORTH SHORE HOSPITAL, Item Number: 6010771601; 14) MTS,NEURO,KIT, Item Number: 600602914; 15) MTS,NEURO,KIT,2,NEWENGLAND MED CTR, Item Number: 601400111; 16) MTS,NEURO,KIT,YLW&RED,FLORIDA HOSP, Item Number: 600604423; 17) MTS,NEURO,KIT-JOHN,F,KENNEDY MED CENTER, Item Number: 60110552; 18) MTS,NEURO,KIT-OVERLOOK HOSPITAL PG, Item Number: 60150035; 19) MTS,NEURO,SPIKE,KIT,CAPITAL HLTHSYS-FULD, Item Number: 60182723; 20) MTS,NEURO-RADIOLOGY,KIT-YALE-NEWHAVEN, Item Number: 602500214; 21) MTS,STROKE/EMBO,KIT,NORTH SHORE UNIV, Item Number: 601403921; 22) MTS,YELLOW,/,RED,MULTILINE,KIT,MAIMONIDE, Item Number: 601305210; 23) MTS,YELLOW,/,RED,MULTILINE,KIT,MAIMONIDE, Item Number: 601400110;
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-0765-2025. 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.