FDA-Device2025-01-22Class I
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
MEDLINE INDUSTRIES, LP - Northfield
Hazard
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.
Sold states
US Nationwide Distribution
Affected count
3930 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
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;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0765-2025Don't want to check this manually?
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