FDAClass IJanuary 22, 2025

Medline Fluid Delivery Set with Drip Chamber: 1) MTO recall

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;

Why was Medline Fluid Delivery Set with Drip Chamber: 1) MTO recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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;

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;
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
3930 units
Distribution
US Nationwide Distribution
Recall date
January 22, 2025
Classification
Class I
Status
Ongoing
Agency
FDA (device)
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