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FDA (Device enforcement)Recalled 2026-05-12class ii

ICU Medical, Inc.: IV Sets with drip chambers

Is my product affected?

IV Sets with drip chambers

  • UPC 20887787005633
  • UPC 20887787005640
  • UPC 20887787005664
  • UPC 20887787005961
  • UPC 20887787005985
  • UPC 20887787005992
  • UPC 20887787006005
  • UPC 20887787006029
  • UPC 20887787006142
  • UPC 20887787006449
  • UPC 20887787006418
  • UPC 20887787006340
  • UPC 20887787006319
  • UPC 20887787006289
  • UPC 20887787006265
  • UPC 10887709102016
  • UPC 20887787006258
  • UPC 20887787005329
  • UPC 20887787005923
  • UPC 20887787005930
  • UPC 20887787005947
  • UPC 10887709004112
  • UPC 10887709055626
  • UPC 10887709083407
  • UPC 10887709083414
  • UPC 20887787009303
  • UPC 20887787009273
  • UPC 20887787009280
  • UPC 10887709120218
  • UPC 20887787009297
  • UPC 10840619024021
  • UPC 10840619024069
  • UPC 10840619024120
  • UPC 10840619064409
  • UPC 10887709085715
  • UPC 10887709051895
  • UPC 10887709040141
  • UPC 20887709120208
  • UPC 10887709020518
  • UPC 10887709020907

Check against the official notice below — it lists the full affected range.

Hazard

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

Details from the source

Reason for recall: Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out. Distribution: Worldwide - US Nationwide distribution including in the states and territories of ND, TX, CT, KY, CO, AR, NC, NJ, VA, MD, OK, AK, IA, IN, KS, OR, CA, OH, WA, GA, AL, SC, MA, HI, FL, NH, NE, MN, MS, SD, MT, NY, DC, ID, WI, PA, AZ, MO, NV, TN, NM, WV, WY, IL, UT, MI, RI, VT, LA, DE, ME, VI, GU, PR and the countries of PK, PH, MY, HK, IN, DE, CR. Quantity: 100,712,657 Lot/code info: All products manufactured on or before 7/4/2026. UDI-DI: 20887787005633 20887787005640 20887787005664 20887787005961 20887787005985 20887787005992 20887787006005 20887787006029 20887787006142 20887787006449 20887787006418 20887787006340 20887787006319 20887787006289 20887787006265 10887709102016 20887787006258 20887787005329 20887787005923 20887787005930 20887787005947 10887709004112 10887709055626 10887709083407 10887709083414 20887787009303 20887787009273 20887787009280 10887709120218 20887787009297 10840619024021 10840619024069 10840619024120 10840619064409 10887709085715 10887709051895 10887709040141 20887709120208 10887709020518 10887709020907 10887709022017 10887709022215 10887709022352 10887709022444 10887709022871 10887709022987 10887709023090 10887709023601 10887709024110 10887709024257 10887709024295 10887709024578 10887709024967 10887709026886 10887709028248 10887709028965 10887709028972 10887709030074 10887709031132 10887709031941 10887709032801 10887709033549 10887709034089 10887709034379 10887709034546 10887709034874 10887709058597 10887709059235 10887709059242 10887709044453 10887709059686 10887709035802 10887709035871 10887709065625 10887709065632 10887709101705 10887709101767 30887709100221 10887709101712 10887709101750 20887709100224 20887709100231 20887709100293 10840619099388 10887709101736 30887709100320 20887709100323 30887709100528 10887709101743 20887787009303

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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