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Lower risk Medical device recall · FDA · Published July 29, 2019

ICU Medical Plum Microbore Infusion Sets with Inline Filters: Fluid Leakage Risk

ICU Medical recalls Plum Microbore Infusion Sets with Inline Filters labeled as Primary due to potential fluid leakage from air vents. Affected units have specific product codes and lot numbers. Consumers should check their units and contact the company for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0127-2020Medical deviceICU Medical ›
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Contact the company

Recalling firmICU Medical Inc600 N Field Dr · Lake Forest, IL 60045-4835
✎ GovInfoNow plain-language explainer

ICU Medical is recalling Plum Microbore Infusion Sets with Inline Filters labeled as Primary because they may leak fluid from air vents. This could cause issues with IV administration if not addressed. Read more at govinfonow.com/recall/67293-icu-medical-plum-microbore-infusion-sets-with-inline-filters-fluid.

Source Summary by GovInfoNow · govinfonow.com/recall/67293-icu-medical-plum-microbore-infusion-sets-with-inline-filters-fluid · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0127-2020

Cite this page

“ICU Medical Plum Microbore Infusion Sets with Inline Filters: Fluid Leakage Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67293-icu-medical-plum-microbore-infusion-sets-with-inline-filters-fluid. Based on FDA recall #Z-0127-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0127-2020%22&limit=1).

ICU Medical, Inc. recalled Plum Microbore Infusion Sets with inline filters labeled as primary due to potential fluid leakage from air vents, according to the FDA on July 29, 2019.

How to tell if you have it

  • Brand: ICU Medical
  • Product: Plum Microbore Infusion Sets with Inline Filters labeled as Primary
  • Description: PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock, 104 Inch
  • Product Code: 142560488
  • Lot numbers (UDI Number): 865455H (20887787005237, 10887787005230), 896215H (20887787005237, 10887787005230), 897455H (20887787005237, 10887787005230), 3864785 (20887787005237, 10887787005230), 4095291 (20887787005237, 10887787005230)
  • Quantity: 78,877 units

The hazard

The recall addresses the potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Context

GovInfoNow's records show ICU Medical, Inc. has 60 other recalls on record since June 15, 2017. Other recent recalls include the ICU Medical CADD Yellow Medication Cassette Reservoir Recall (August 20, 2026), the ICU Medical Hotline Fluid Warming Set Recall (June 24, 2026), and a recall for product code 60004087 (June 10, 2026). Other recent recalls of similar products include B Braun Medical Infusomat pumps may cause medication backflow in IV systems (October 29, 2025), B Braun Medical IV Sets Recall: Backflow Risk in Gravity/Pump Systems (October 29, 2025), and B Braun Medical Blood Set Recall: Risk of Medication Backflow (October 29, 2025).

How to tell if you have this one

Check for Plum Microbore Infusion Sets with Inline Filters labeled as Primary. Product codes include 142560488, and lot numbers like 865455H, 896215H, 897455H, 3864785, or 4095291.

  • Brand
    ICU Medical
  • Category
    Medical device
FDA recall event · 22 products

All 22 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY. International distribution to Canada, Chile, France, Germany, Greece, Hong Kong, Ireland, Italy, Oman, Philippines, Poland, Saudi Arabia, South Africa, Spain, Taiwan, Turkey, United Arab Emirates, United Kingdom.
Recall numberProduct, codes & lotsQuantity
Z-0126-2020Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as High-Pressure Filter PRIMARY I.V. PLUMSET Convetible Pin, 104 Inch with Orange Polyethylene-Lined*/Light Resistant Tubing, Prepierced Injection Site and OPTION-LOK. 1 unit per pouch; 48 pouches per case.; Product Code: 118790412, Lot number (UDI Number): 855505H (20887787009020, 10887787009023), 865135H (20887787009020, 10887787009023), 918695H (20887787009020, 10887787009023), 928085H (20887787009020, 10887787009023), 937325H (20887787009020, 10887787009023), 3864774 (20887787009020, 10887787009023), 3935434 (20887787009020, 10887787009023), 4011065 (20887787009020, 10887787009023), 4088425 (20887787009020, 10887787009023)170,735 units
Z-0127-2020Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 0.2 Micron Filter, Prepierced Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock, 104 Inch. 1 unit per pouch; 50 pouches per case; Product Code: 142560488, Lot number (UDI Number): 865455H (20887787005237, 10887787005230), 896215H (20887787005237, 10887787005230), 897455H (20887787005237, 10887787005230), 3864785 (20887787005237, 10887787005230), 4095291 (20887787005237, 10887787005230);78,877 units
Z-0128-2020Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set Yellow Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, Secure Lock, 107 Inch. 1 unit per pouch; 48 pouches per case; Product Code: 149530489, Lot number (UDI Number): 925155H (20887787003226, 10887787003229)1,536 units
Z-0129-2020Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch. 1 unit per pouch; 50 pouches per case; Product Code: 163350455, Lot number (UDI Number): 855935H (20887787007316, 10887787007319), 855965H (20887787007316, 10887787007319), 876145H (20887787007316, 10887787007319), 885395H (20887787007316, 10887787007319), 896135H (20887787007316, 10887787007319), 936605H (20887787007316, 10887787007319), 3843263 (20887787007316, 10887787007319), 3864786 (20887787007316, 10887787007319)73,710 units
Z-0130-2020Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set, Microbore, CLAVE Y-Site, 118 Inch. 1 unit per pouch; 50 pouches per case; Product Code: 163620455, Lot number (UDI Number): 855645H (20887787007354, 10887787007357), 885415H (20887787007354, 10887787007357), 896625H (20887787007354, 10887787007357), 4008547 (10887787007357, 20887787007354)45,900 units
Z-0131-2020Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case; Product Code: 163630455, Lot number (UDI Number): 876175H (20887787007361, 10887787007364), 885385H (20887787007361, 10887787007364), 896995H (20887787007361, 10887787007364), 908235H (20887787007361, 10887787007364), 925755H (20887787007361, 10887787007364), 3843264 (20887787007361, 10887787007364)155,150 units
Z-0132-2020Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. 1 unit per pouch; 50 pouches per case; Product Code: 163730455, Lot number (UDI Number): 896225H (20887787007408, 10887787007401), 916845H (20887787007408, 10887787007401), 925825H (20887787007408, 10887787007401), 948155H (20887787007408, 10887787007401)26,700 units
Z-0133-2020Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch. 1 unit per pouch; 50 pouches per case; Product Code: 163830455, Lot number (UDI Number): 855665H (20887787007439, 10887787007432), 865495H (20887787007439, 10887787007432), 896195H (20887787007439, 10887787007432), 3849197 (20887787007439, 10887787007432), 4064964 (20887787007439, 10887787007432)51,250 units
Z-0134-2020Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case; Product Code: 163840455, Lot number (UDI Number): 855995H (20887787007446, 10887787007449), 865505H (20887787007446, 10887787007449), 876185H (20887787007446, 10887787007449)19,350 units
Z-0135-2020Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per pouch; 50 pouches per case; Product Code: 240100401, Lot number (UDI Number): 897525H (20887787009259, 10887787009252), 905915H (20887787009259, 10887787009252), 926235H (20887787009259, 10887787009252)4,600 units
Z-0136-2020Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PRIMARY PLUMSET 15 Micron Filter in Sight Chamber, CLAVE Port, 0.2 Micron Filter, CLAVE Y-Site, PE Lined Light Resistant Tubing, Distal Microbore Tubing 272 cm / 15 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S.; Product Code: 140099238, Lot number 855565H14,850 units
Z-0137-2020Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 272 cm / 15 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S.; Product Code: 140099290, Lot number 855575H, 865265H, 876065H, 885425H, 896175H, 918685H, 929095H, 925775H, 936455H, 945745H, 3849199, 3845287, 3864779.280,826 units
Z-0138-2020Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, CLAVE Y-Site, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 272 cm / 15 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S.; Product Code: 140099291, Lot number (UDI Number): 3981726 (10887709100166, 20887709100163), 4065006 (10887709100166, 20887709100163)6,400 units
Z-0139-2020Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as Primary PLUM Set, 15 Micron Filter in Sight Chamber, CLAVE Secondary Port, 0.2 Micron Filter, Polyethylene Lined Light Resistant Tubing, Distal Microbore Tubing, Secure Lock 269 cm / 14 mL. 1 unit per pouch; 50 pouches per case. Not distributed in the U.S.; Product Code: 154413190, Lot number 4105785521 units
Z-0140-2020Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case . Not distributed in the U.S.; Product Code: 163353155, Lot number 885685H, 39597572,327 units
Z-0141-2020Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case . Not distributed in the U.S.; Product Code: 163359255, Lot number 855875H, 866155H, 876265H, 885645H, 887125H, 905965H, 945565H32,416 units
Z-0142-2020Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, 293 cm / 8.1 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case. Not distributed in the U.S.; Product Code: 163459255, Lot number 855755H, 876275H, 905975H5,443 units
Z-0143-2020Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case . Not distributed in the U.S.; Product Code: 163633155, Lot number 937585H, 3959758400 units
Z-0144-2020Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case . Not distributed in the U.S.; Product Code: 163639255, Lot number 855735H, 866165H, 897465H, 907305H, 929285H, 929425H6,516 units
Z-0145-2020Infusion Pump I.V. Administration, specifically Plum Microbore Infusion Sets with Inline Filters labeled as PLUM Epidural Set with NRFit Connector Yellow-Striped Tubing, Distal Microbore Tubing, 0.2 Micron Filter, 107 Inch. 1 unit per pouch; 48 pouches per case; Product Code: 240070401, Lot number (UDI Number): 896485H (20887787009228, 10887787009221), 915625H (20887787009228, 10887787009221), 3850054 (20887787009228, 10887787009221)7,920 units
Z-0146-2020Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case. Not distributed in the U.S.; Product Code: 240119201, Lot number 916205H120 units
Z-0147-2020Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case; Product Code: 240130401, Lot number (UDI Number): 885585H (20887787009266, 10887787009269), 925855H (20887787009266, 10887787009269),50 units
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Review the product code and lot numbers listed in the recall notice to confirm if your set is affected.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 50 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VI, VT, WA, WI, WV, WY.…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 4.5 years after the firm started it.

1. Firm started the recall: Jul 29, 201912. FDA classified it Class II: Oct 14, 201923. Published in FDA’s Enforcement Report: Oct 23, 201934. FDA terminated the recall: Jan 12, 2024420192024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What should I do if I have the affected set?

Contact ICU Medical directly to confirm if your set is affected and follow their instructions for next steps.

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0127-2020 (July 29, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0127-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA