Medline Fluid Delivery Set with Drip Chamber: 1) MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, Item Num...
FDA Device Recall #Z-0765-2025 — Class I — December 16, 2024
Recall Summary
| Recall Number | Z-0765-2025 |
| Classification | Class I — Serious risk |
| Date Initiated | December 16, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 3930 units |
Product Description
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.
Distribution Pattern
US Nationwide Distribution
Lot / Code Information
1) 60130527 UDI-D:10193489046465(each), 20193489046462(case), Lot Number:0000133032; 2) 65111341 UDI-D:10193489061314(each), 20193489061311(case), Lot Number:0000129541; 3) 65111341 UDI-D:10193489061314(each), 20193489061311(case), Lot Number:0000134701; 4) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000129544; 5) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000128715; 6) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000133060; 7) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000131657; 8) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000135723; 9) 65232486 UDI-D:10193489063950(each), 20193489063957(case), Lot Number:0000135294; 10) 65071193 UDI-D:10193489060904(each), 20193489060901(case), Lot Number:0000130171; 11) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000135606; 12) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000134729; 13) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000137115; 14) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000130833; 15) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000131669; 16) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000129513; 17) 600604422 UDI-D:10193489070224(each), 20193489070221(case), Lot Number:0000128721; 18) 60100045 UDI-D:10193489044928(each), 30193489044922(case), Lot Number:0000129523; 19) 60100045 UDI-D:10193489044928(each), 30193489044922(case), Lot Number:0000132393; 20) 60100045 UDI-D:10193489044928(each), 30193489044922(case), Lot Number:0000134940; 21) 60100045 UDI-D:10193489044928(each), 30193489044922(case), Lot Number:0000144158; 22) 60100045 UDI-D:10193489044928(each), 30193489044922(case), Lot Number:0000139082; 23) 650801715 UDI-D:10193489075458(each), 20193489075455(case), Lot Number:0000130138; 24) 650801715 UDI-D:10193489075458(each), 20193489075455(case), Lot Number:0000132350; 25) 650801715 UDI-D:10193489075458(each), 20193489075455(case), Lot Number:0000135736; 26) 60232481 UDI-D:10193489053326(each), 30193489053320(case), Lot Number:0000129534; 27) 60120583 UDI-D:10193489045864(each), 30193489045868(case), Lot Number:0000133660; 28) 60120583 UDI-D:10193489045864(each), 30193489045868(case), Lot Number:0000136501; 29) 60120583 UDI-D:10193489045864(each), 30193489045868(case), Lot Number:0000131600; 30) 601403920 UDI-D:10193489071498(each), 30193489071492(case), Lot Number:0000131376; 31) 601403920 UDI-D:10193489071498(each), 30193489071492(case), Lot Number:0000130940; 32) 62140602 UDI-D:10193489057805(each), 30193489057809(case), Lot Number:0000132222; 33) 62140602 UDI-D:10193489057805(each), 30193489057809(case), Lot Number:0000141215; 34) 602301614 UDI-D:10193489072754(each), 30193489072758(case), Lot Number:0000133659; 35) 6010771601 UDI-D:10193489099843(each), 30193489099847(case), Lot Number:0000127859; 36) 600602914 UDI-D:10193489070170(each), 30193489070174(case), Lot Number:0000135717; 37) 600602914 UDI-D:10193489070170(each), 30193489070174(case), Lot Number:0000128447; 38) 601400111 UDI-D:10193489071344(each), 30193489071348(case), Lot Number:0000133121; 39) 601400111 UDI-D:10193489071344(each), 30193489071348(case), Lot Number:0000130573; 40) 600604423 UDI-D:10193489070231(each), 30193489070235(case), Lot Number:0000128607; 41) 600604423 UDI-D:10193489070231(each), 30193489070235(case), Lot Number:0000137751; 42) 60110552 UDI-D:10193489045611(each), 30193489045615(case), Lot Number:0000131878; 43) 60110552 UDI-D:10193489045611(each), 30193489045615(case), Lot Number:0000130577; 44) 60110552 UDI-D:10193489045611(each), 30193489045615(case), Lot Number:0000138084; 45) 60150035 UDI-D:10193489048292(each), 30193489048296(case), Lot Number:0000130187; 46) 60150035 UDI-D:10193489048292(each), 30193489048296(case), Lot Number:0000131883; 47) 60150035 UDI-D:10193489048292(each), 30193489048296(case), Lot Number:0000143095; 48) 60182723 UDI-D:10193489049817(each), 30193489049811(case), Lot Number:0000130988; 49) 602500214 UDI-D:10193489072815(each), 30193489072819(case), Lot Number:0000127874; 50) 601403921 UDI-D:30193489071508(each), 30193489071508(case), Lot Number:0000131619; 51) 601403921 UDI-D:30193489071508(each), 30193489071508(case), Lot Number:0000133025; 52) 601403921 UDI-D:30193489071508(each), 30193489071508(case), Lot Number:0000136559; 53) 601305210 UDI-D:10193489070989(each), 30193489070983(case), Lot Number:0000130984; 54) 601400110 UDI-D:10193489071337(each), 30193489071331(case), Lot Number:0000128757;
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.