MEDLINE INDUSTRIES, LP - Northfield recalls Medline Fluid Delivery Set with Drip Chamber: 1) MTO
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
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;
Lot / code information
- Lot #
- 0000133032; 2) 65111341 UDI-D:10193489061314(each), 20193489061311(case)
- Lot #
- 0000129541; 3) 65111341 UDI-D:10193489061314(each), 20193489061311(case)
- Lot #
- 0000134701; 4) 65232486 UDI-D:10193489063950(each), 20193489063957(case)
- Lot #
- 0000129544; 5) 65232486 UDI-D:10193489063950(each), 20193489063957(case)
- Lot #
- 0000128715; 6) 65232486 UDI-D:10193489063950(each), 20193489063957(case)
- Lot #
- 0000133060; 7) 65232486 UDI-D:10193489063950(each), 20193489063957(case)
- Lot #
- 0000131657; 8) 65232486 UDI-D:10193489063950(each), 20193489063957(case)
- Lot #
- 0000135723; 9) 65232486 UDI-D:10193489063950(each), 20193489063957(case)
- Lot #
- 0000135294; 10) 65071193 UDI-D:10193489060904(each), 20193489060901(case)
- Lot #
- 0000130171; 11) 600604422 UDI-D:10193489070224(each), 20193489070221(case)
- Lot #
- 0000135606; 12) 600604422 UDI-D:10193489070224(each), 20193489070221(case)
- Lot #
- 0000134729; 13) 600604422 UDI-D:10193489070224(each), 20193489070221(case)
- Lot #
- 0000137115; 14) 600604422 UDI-D:10193489070224(each), 20193489070221(case)
- Lot #
- 0000130833; 15) 600604422 UDI-D:10193489070224(each), 20193489070221(case)
- Lot #
- 0000131669; 16) 600604422 UDI-D:10193489070224(each), 20193489070221(case)
- Lot #
- 0000129513; 17) 600604422 UDI-D:10193489070224(each), 20193489070221(case)
- Lot #
- 0000128721; 18) 60100045 UDI-D:10193489044928(each), 30193489044922(case)
- Lot #
- 0000129523; 19) 60100045 UDI-D:10193489044928(each), 30193489044922(case)
- Lot #
- 0000132393; 20) 60100045 UDI-D:10193489044928(each), 30193489044922(case)
- Lot #
- 0000134940; 21) 60100045 UDI-D:10193489044928(each), 30193489044922(case)
- Lot #
- 0000144158; 22) 60100045 UDI-D:10193489044928(each), 30193489044922(case)
- Lot #
- 0000139082; 23) 650801715 UDI-D:10193489075458(each), 20193489075455(case)
- Lot #
- 0000130138; 24) 650801715 UDI-D:10193489075458(each), 20193489075455(case)
- Lot #
- 0000132350; 25) 650801715 UDI-D:10193489075458(each), 20193489075455(case)
- Lot #
- 0000135736; 26) 60232481 UDI-D:10193489053326(each), 30193489053320(case)
- Lot #
- 0000129534; 27) 60120583 UDI-D:10193489045864(each), 30193489045868(case)
- Lot #
- 0000133660; 28) 60120583 UDI-D:10193489045864(each), 30193489045868(case)
- Lot #
- 0000136501; 29) 60120583 UDI-D:10193489045864(each), 30193489045868(case)
- Lot #
- 0000131600; 30) 601403920 UDI-D:10193489071498(each), 30193489071492(case)
- Lot #
- 0000131376; 31) 601403920 UDI-D:10193489071498(each), 30193489071492(case)
- Lot #
- 0000130940; 32) 62140602 UDI-D:10193489057805(each), 30193489057809(case)
- Lot #
- 0000132222; 33) 62140602 UDI-D:10193489057805(each), 30193489057809(case)
- Lot #
- 0000141215; 34) 602301614 UDI-D:10193489072754(each), 30193489072758(case)
- Lot #
- 0000133659; 35) 6010771601 UDI-D:10193489099843(each), 30193489099847(case)
- Lot #
- 0000127859; 36) 600602914 UDI-D:10193489070170(each), 30193489070174(case)
- Lot #
- 0000135717; 37) 600602914 UDI-D:10193489070170(each), 30193489070174(case)
- Lot #
- 0000128447; 38) 601400111 UDI-D:10193489071344(each), 30193489071348(case)
- Lot #
- 0000133121; 39) 601400111 UDI-D:10193489071344(each), 30193489071348(case)
- Lot #
- 0000130573; 40) 600604423 UDI-D:10193489070231(each), 30193489070235(case)
- Lot #
- 0000128607; 41) 600604423 UDI-D:10193489070231(each), 30193489070235(case)
- Lot #
- 0000137751; 42) 60110552 UDI-D:10193489045611(each), 30193489045615(case)
- Lot #
- 0000131878; 43) 60110552 UDI-D:10193489045611(each), 30193489045615(case)
- Lot #
- 0000130577; 44) 60110552 UDI-D:10193489045611(each), 30193489045615(case)
- Lot #
- 0000138084; 45) 60150035 UDI-D:10193489048292(each), 30193489048296(case)
- Lot #
- 0000130187; 46) 60150035 UDI-D:10193489048292(each), 30193489048296(case)
- Lot #
- 0000131883; 47) 60150035 UDI-D:10193489048292(each), 30193489048296(case)
- Lot #
- 0000143095; 48) 60182723 UDI-D:10193489049817(each), 30193489049811(case)
- Lot #
- 0000130988; 49) 602500214 UDI-D:10193489072815(each), 30193489072819(case)
- Lot #
- 0000127874; 50) 601403921 UDI-D:30193489071508(each), 30193489071508(case)
- Lot #
- 0000131619; 51) 601403921 UDI-D:30193489071508(each), 30193489071508(case)
- Lot #
- 0000133025; 52) 601403921 UDI-D:30193489071508(each), 30193489071508(case)
- Lot #
- 0000136559; 53) 601305210 UDI-D:10193489070989(each), 30193489070983(case)
- Lot #
- 0000130984; 54) 601400110 UDI-D:10193489071337(each), 30193489071331(case)
- Lot #
- 0000128757
Show 44 more code fieldsShow fewer
What the firm is doing
An IMMEDIATE ACTION REQUIRED MEDICAL DEVICE RECALL notification letter dated 12/16/24 was sent to customers. REQUIRED ACTION: 1. Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-24-270-FG Recall Code: 4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. Update: A follow-up letter titled IMMEDIATE ACTION REQUIRED dated 2/11/25 was sent to customers. Medline would like to update our action to instruct you to please destroy all impacted convenience kits and Medline will provide replacement kit(s) with the correct Fluid Delivery Set. REQUIRED ACTION: 1. Immediately check your stock for the affected kit number(s) and lot number(s) listed on the attachment. Please destroy all affected kits. 2. Please complete and return the enclosed destruction form listing the quantity of affected kits destroyed. Even if you do not have any affected product, please complete and return the form. 3. Upon receipt of your completed destruction form, Medline will issue replacem
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US Nationwide Distribution
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0765-2025
- FDA device classification · OEZOfficial FDA classification for this device type
- CFR regulation · 21 CFR 870.1200The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find MEDLINE INDUSTRIES, LP - NorthfieldSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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