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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Medline Fluid Delivery Sets Recalled for Drip Chamber Assembly Error

Agency Publication Date: January 15, 2025
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Summary

Medline Industries, LP has recalled 17,530 Fluid Delivery Sets because they 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, which can lead to over-dosing or fluid overload. The recalled products include various neuro, radiology, and angiography kits distributed nationwide in the United States.

Risk

The use of these incorrectly assembled sets may result in patients receiving three times the intended amount of fluid or medication. This poses a critical risk of fluid overload or dangerous medication errors that could lead to serious injury or death, though no injuries have been reported to date.

What You Should Do

  1. The recalled products are Medline Fluid Delivery Sets with Drip Chambers, including specialized neuro, radiology, and angiography kits as well as general delivery sets. Affected models were sold under various Item Numbers including 99000069, 949000222, 949000224, 949000221, 949000223, 60130527, 65111341, and 65232486.
  2. Check your clinical inventory for products matching the specific Item Numbers and Lot Numbers provided. Affected units were incorrectly assembled with a white macro drip chamber instead of the required grey micro drip chamber. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
  4. For questions regarding this recall, contact Medline Industries, LP at their Northfield, Illinois facility or through your primary Medline sales representative.
  5. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for additional information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medline Fluid Delivery Set with Drip Chamber (Recall Z-0764-2025)
Variants: FDS,135,CHMN,W/F,MLL,RC(2),PG, FDS,135,NV,MICRO-CHAMBER,W/FILTER,BLUE, FDS,135,NV,MICRO-CHAMBER,W/FILTER,GREEN, FDS,135,NV,MICRO-CHAMBER,W/FILTER,RED, FDS,135,NV,MICRO-CHAMBER,W/FILTER,YELLOW
Model / REF:
99000069
949000222
949000224
949000221
949000223
Lot Numbers:
0000128741
0000134505
0000133893
0000135769
0000139596
0000133018
0000136573
0000133036
0000133031
UDI:
10193489069587
30193489069581
10197344018550
30197344018554
10197344018642
30197344018646
10197344018567
30197344018561
10197344018543
30197344018547

13,600 units affected in this group.

Product: Medline Fluid Delivery Set with Drip Chamber (Recall Z-0765-2025)
Variants: MTO,135,YELLOW,MICRO,SPK-MAIMONIDES, MTO,ANGIO,DOUBLE,SPIKE,KIT,KENNEDY HLTH, MTO,ANGIO,SINGLE,SPIKE,KIT, MTO,ANGIO,SINGLE,SPIKE,KIT,GOOD,SAM, MTO,NEURO,FLUSH,SPIKE,KIT,BLUE,FLORIDA, MTO,NEURO,KIT,-,JERSEY,SHORE PG, MTO,RADIOLOGY,KIT,HAMOT MED CEN, MTS,135,CDS,IV,TUBE-JEFFERSON UNIV., MTS,135,YELLOW,MICRO,SPIKE,LUTHERAN MED, MTS,ANGIO,NEURO,KIT,NORTH SHORE UNIV, MTS,CUST. FILTER-NEWYORK UNIVERSITY, MTS,INTERV,NEURO,KIT-WESTCHESTER,MC, MTS,NEU,NORTH SHORE HOSPITAL, MTS,NEURO,KIT, MTS,NEURO,KIT,2,NEWENGLAND MED CTR, MTS,NEURO,KIT,YLW&RED,FLORIDA HOSP, MTS,NEURO,KIT-JOHN,F,KENNEDY MED CENTER, MTS,NEURO,KIT-OVERLOOK HOSPITAL PG, MTS,NEURO,SPIKE,KIT,CAPITAL HLTHSYS-FULD, MTS,NEURO-RADIOLOGY,KIT-YALE-NEWHAVEN, MTS,STROKE/EMBO,KIT,NORTH SHORE UNIV, MTS,YELLOW,/,RED,MULTILINE,KIT,MAIMONIDE
Model / REF:
60130527
65111341
65232486
65071193
600604422
60100045
650801715
60232481
60120583
601403920
62140602
602301614
6010771601
600602914
601400111
600604423
60110552
60150035
60182723
602500214
601403921
601305210
601400110
Lot Numbers (54):
0000133032
0000129541
0000134701
0000129544
0000128715
0000133060
0000131657
0000135723
0000135294
0000130171
0000135606
0000134729
0000137115
0000130833
0000131669
0000129513
0000128721
0000129523
0000132393
0000134940
0000144158
0000139082
0000130138
0000132350
0000135736
0000129534
0000133660
0000136501
0000131600
0000131376
0000130940
0000132222
0000141215
0000133659
0000127859
0000135717
0000128447
0000133121
0000130573
0000128607
0000137751
0000131878
0000130577
0000138084
0000130187
0000131883
0000143095
0000130988
0000127874
0000131619
UDI:
10193489046465
20193489046462
10193489061314
20193489061311
10193489063950
20193489063957
10193489060904
20193489060901
10193489070224
20193489070221
10193489044928
30193489044922
10193489075458
20193489075455
10193489053326
30193489053320
10193489045864
30193489045868
10193489071498
30193489071492
10193489057805
30193489057809
10193489072754
30193489072758
10193489099843
30193489099847
10193489070170
30193489070174
10193489071344
30193489071348
10193489070231
30193489070235
10193489045611
30193489045615
10193489048292
30193489048296
10193489049817
30193489049811
10193489072815
30193489072819
30193489071508
10193489070989
30193489070983
10193489071337
30193489071331

3,930 units affected in this group.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95988
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Hospital supply distributors; Medline Industries; Direct medical facility sales
Manufactured In: United States
Units Affected: 2 products (13,600 units; 3930 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.