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Update on Alert: Fluid Delivery Set Issue from Medline

This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. The affected products and recommendations for what to do with the devices below have not changed.

Affected Product

Medline Fluid Delivery Set showing Grey=Micro Drip Chamber (left) and White = Macro Drip Chamber (right)

 

The FDA is aware that Medline has issued a letter to affected health care providers recommending certain lots of Fluid Delivery Sets with Drip Chamber within Medline custom kits be removed from use.

Medline Item NumberDescriptionLot NumberUDI (each)UDI (case)
99000069FDS, 135, CHMN, W/F, MLL, RC(2), PG00001287411019348906958730193489069581
99000069FDS, 135, CHMN, W/F, MLL, RC(2), PG00001345051019348906958730193489069581
99000069FDS, 135, CHMN, W/F, MLL, RC(2), PG00001338931019348906958730193489069581
99000069FDS, 135, CHMN, W/F, MLL, RC(2), PG00001357691019348906958730193489069581
99000069FDS, 135, CHMN, W/F, MLL, RC(2), PG00001395961019348906958730193489069581
949000222FDS, 135, NV, MICRO-CHAMBER, W/FILTER, BLUE00001330181019734401855030197344018554
949000224FDS, 135, NV, MICRO-CHAMBER, W/FILTER, GREEN00001365731019734401864230197344018646
949000221FDS, 135, NV, MICRO-CHAMBER, W/FILTER, RED00001330361019734401856730197344018561
949000223FDS, 135, NV, MICRO-CHAMBER, W/FILTER, YELLOW00001330311019734401854330197344018547
60130527MTO, 135, YELLOW, MICRO, SPK-MAIMONIDES00001330321019348904646520193489046462
65111341MTO, ANGIO, DOUBLE, SPIKE, KIT, KENNEDY HLTH00001295411019348906131420193489061311
65111341MTO, ANGIO, DOUBLE, SPIKE, KIT, KENNEDY HLTH00001347011019348906131420193489061311
65232486MTO, ANGIO, SINGLE, SPIKE, KIT00001295441019348906395020193489063957
65232486MTO, ANGIO, SINGLE, SPIKE, KIT00001287151019348906395020193489063957
65232486MTO, ANGIO, SINGLE, SPIKE, KIT00001330601019348906395020193489063957
65232486MTO, ANGIO, SINGLE, SPIKE, KIT00001316571019348906395020193489063957
65232486MTO, ANGIO, SINGLE, SPIKE, KIT00001357231019348906395020193489063957
65232486MTO, ANGIO, SINGLE, SPIKE, KIT00001352941019348906395020193489063957
65071193MTO, ANGIO, SINGLE, SPIKE, KIT, GOOD, SAM00001301711019348906090420193489060901
600604422MTO, NEURO, FLUSH, SPIKE, KIT, BLUE, FLORIDA00001356061019348907022420193489070221
600604422MTO, NEURO, FLUSH, SPIKE, KIT, BLUE, FLORIDA00001347291019348907022420193489070221
600604422MTO, NEURO, FLUSH, SPIKE, KIT, BLUE, FLORIDA00001371151019348907022420193489070221
600604422MTO, NEURO, FLUSH, SPIKE, KIT, BLUE, FLORIDA00001308331019348907022420193489070221
600604422MTO, NEURO, FLUSH, SPIKE, KIT, BLUE, FLORIDA00001316691019348907022420193489070221
600604422MTO, NEURO, FLUSH, SPIKE, KIT, BLUE, FLORIDA00001295131019348907022420193489070221
600604422MTO, NEURO, FLUSH, SPIKE, KIT, BLUE, FLORIDA00001287211019348907022420193489070221
60100045MTO, NEURO, KIT, -, JERSEY, SHORE PG00001295231019348904492830193489044922
60100045MTO, NEURO, KIT, -, JERSEY, SHORE PG00001323931019348904492830193489044922
60100045MTO, NEURO, KIT, -, JERSEY, SHORE PG00001349401019348904492830193489044922
60100045MTO, NEURO, KIT, -, JERSEY, SHORE PG00001441581019348904492830193489044922
60100045MTO, NEURO, KIT, -, JERSEY, SHORE PG00001390821019348904492830193489044922
650801715MTO, RADIOLOGY, KIT, HAMOT MED CEN00001301381019348907545820193489075455
650801715MTO, RADIOLOGY, KIT, HAMOT MED CEN00001323501019348907545820193489075455
650801715MTO, RADIOLOGY, KIT, HAMOT MED CEN00001357361019348907545820193489075455
60232481MTS, 135, CDS, IV, TUBE-JEFFERSON UNIV.00001295341019348905332630193489053320
60120583MTS, 135, YELLOW, MICRO, SPIKE, LUTHERAN MED00001336601019348904586430193489045868
60120583MTS, 135, YELLOW, MICRO, SPIKE, LUTHERAN MED00001365011019348904586430193489045868
60120583MTS, 135, YELLOW, MICRO, SPIKE, LUTHERAN MED00001316001019348904586430193489045868
601403920MTS, ANGIO, NEURO, KIT, NORTH SHORE UNIV00001313761019348907149830193489071492
601403920MTS, ANGIO, NEURO, KIT, NORTH SHORE UNIV00001309401019348907149830193489071492
62140602MTS, CUST. FILTER-NEWYORK UNIVERSITY00001322221019348905780530193489057809
62140602MTS, CUST. FILTER-NEWYORK UNIVERSITY00001412151019348905780530193489057809
602301614MTS, INTERV, NEURO, KIT-WESTCHESTER, MC00001336591019348907275430193489072758
6010771601MTS, NEU, NORTH SHORE HOSPITAL00001278591019348909984330193489099847
600602914MTS, NEURO, KIT00001357171019348907017030193489070174
600602914MTS, NEURO, KIT00001284471019348907017030193489070174
601400111MTS, NEURO, KIT, 2, NEWENGLAND MED CTR00001331211019348907134430193489071348
601400111MTS, NEURO, KIT, 2, NEWENGLAND MED CTR00001305731019348907134430193489071348
600604423MTS, NEURO, KIT, YLW&RED, FLORIDA HOSP00001286071019348907023130193489070235
600604423MTS, NEURO, KIT, YLW&RED, FLORIDA HOSP00001377511019348907023130193489070235
60110552MTS, NEURO, KIT-JOHN, F, KENNEDY MED CENTER00001318781019348904561130193489045615
60110552MTS, NEURO, KIT-JOHN, F, KENNEDY MED CENTER00001305771019348904561130193489045615
60110552MTS, NEURO, KIT-JOHN, F, KENNEDY MED CENTER00001380841019348904561130193489045615
60150035MTS, NEURO, KIT-OVERLOOK HOSPITAL PG00001301871019348904829230193489048296
60150035MTS, NEURO, KIT-OVERLOOK HOSPITAL PG00001318831019348904829230193489048296
60150035MTS, NEURO, KIT-OVERLOOK HOSPITAL PG00001430951019348904829230193489048296
60182723MTS, NEURO, SPIKE, KIT, CAPITAL HLTHSYS-FULD00001309881019348904981730193489049811
602500214MTS, NEURO-RADIOLOGY, KIT-YALE-NEWHAVEN00001278741019348907281530193489072819
601403921MTS, STROKE/EMBO, KIT, NORTH SHORE UNIV00001316193019348907150830193489071508
601403921MTS, STROKE/EMBO, KIT, NORTH SHORE UNIV00001330253019348907150830193489071508
601403921MTS, STROKE/EMBO, KIT, NORTH SHORE UNIV00001365593019348907150830193489071508
601305210MTS, YELLOW, /, RED, MULTILINE, KIT, MAIMONIDE00001309841019348907098930193489070983
601400110MTS, YELLOW, /, RED, MULTILINE, KIT, MAIMONIDE00001287571019348907133730193489071331

What to Do

  • On December 16, 2024, Medline sent all affected customers a Medical Device Recall letter recommending the following actions:
    • Immediately check your stock for the affected item number and the affected lot numbers listed above.
    • Confirm whether you received product with the incorrect white macro drip chamber. Fluid Delivery Sets with white macro drip chambers should be discarded. The image below shows the difference in drip chamber colors and should help in identifying impacted devices.
    • If you have received the correct Fluid Delivery Set with a grey micro drip chamber, the product can be safely used.
Photo Medline Fluid Delivery Set Micro Chambers - Grey (left) White (Right)

Reason for Alert

Medline identified Fluid Delivery Sets that 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. As a result, using a Fluid Delivery Set with this incorrect component increases the risk of over-administration of fluids, which may result in swelling (edema), shortness of breath, increased blood pressure, and/or death.

Medline has not reported any injuries associated with this issue.

Device Use

These fluid delivery sets with drip chambers are provided as components convenience kits. Fluid delivery sets prevent air from entering into the IV tubing and regulate the solution's flow rate.

Contact Information

Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Medline’s Recall Department at recalls@medline.com or 866-359-1704.

Additional FDA Resources

Unique Device Identifier (UDI)

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.

How do I report a problem?

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

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