6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Product Numbers / Lot Numbers / UDI Codes: IR-1SF 5727531 01549878920700181724120130100105727531 IR-1S 5728008 01549878920698901724120130100105728008 IR-1SF 5737373 01549878920700181724120130100105737373 IR-1S 5738091 01549878920698901724120130100105738091 IR-1S 5755100 01549878920698901724120130100105755100 P039 5787453 0110840619063112172501013050105787453 MC33769 5664461 0110887709066844172610013050105664461 K7059-001 5692316 0110887709036977172611013050105692316 011-MC100G 5693573 01108406190790141726110130100105693573 LAT-MC100 5714006 01108877090962851726110130100105714006 LAT-MC330021 5714014 0110887709122144172611013050105714014 MC100-DC 5724498 0110887709037165172612013050105724498 MC33636 5725526 0110887709058108172612013050105725526 MC33691 5725559 0110887709064314172612013050105725559 011-MC100RR 5726283 01108406190539771726120130100105726283 011-AM3120 5726777 0110887709098876172612013025105726777 066-MC100 5735598 01108406190842231726120130100105735598 039-MC330487 5736333 0110840619098541172612013025105736333 011-H3095 5737883 0110840619043015172612013025105737883 011-MC330627 5738780 0110887709098531172612013050105738780 MC33687 5744883 0110887709064369172612013050105744883 011-MC330526 5746749 0110887709092232172612013050105746749 011-MC33428 5747264 0110840619072336172612013025105747264 011-MC33830 5747331 0110840619038578172612013025105747331 011-MC33230 5747967 0110840619064492172612013050105747967 MC33324 5753823 0110887709037738172612013025105753823 MC33467 5754104 0110887709039046172612013025105754104 MC33769 5754294 0110887709066844172612013050105754294 011-MC330164 5756448 0110840619091085172612013020105756448 011-MC33108 5757000 0110840619057838172612013050105757000 MC33688 5757503 0110887709064376172612013050105757503 011-MC33727 5758006 0110840619077713172612013050105758006 011-A1027 5759727 0110840619064676172261201350105759727 011-MC330283 5761603 0110840619092914172612013050105761603 MC33324 5762312 0110887709037738172612013025105762312 MC33687 5762576 0110887709064369172612013050105762576 MC33634 5763303 0110887709058085172701013050105763303 K7059-001 5772085 0110887709036977172701013050105772085 MC33481 5772173 0110887709051864172701013025105772173 MC33467 5772198 0110887709039046172701013025105772198 MC33769 5772352 0110887709066844172701013050105772352 011-MC33872 5772480 0110840619081284172701013050105772480 011-MC33183 5773272 0110840619061743172701013050105773272 011-MC33428 5774716 0110840619072336172701013025105774716 011-MC33474 5774726 0110840619066380172701013050105774726 011-MC5006 5775730 0110840619072657172701013025105775730 K7047-001 5777730 01108877090368541727010130100105777730 011-MC330166 5782915 0110840619090064172701013050105782915 011-MC33057 5782920 0110840619055292172701013050105782920 011-MC330631 5782922 0110887709120225172701013050105782922 011-MC33471 5782923 0110840619066212172701013050105782923 011-MC33109 5782941 0110840619057845172701013050105782941 011-MC330074 5785884 0110840619086913172701013050105785884 011-MC33473 5787377 0110840619066403172701013050105787377 011-MC33740 5788332 0110840619078154172701013025105788332 011-MC330283 5788847 0110840619092914172701013050105788847 011-MC33044 5788907 0110840619054684172701013025105788907 011-MC33474 5789113 0110840619066380172701013050105789113 011-MC330074 5797110 0110840619086913172701013050105797110 011-MC33044 5800894 0110840619054684172701013025105800894 MC33481 5800914 0110887709051864172701013025105800914 MC33634 5800955 0110887709058085172701013050105800955 011-AM3120 5801154 0110887709098876172701013025105801154 LAT-MC100 5809570 01108877090962851727020130100105809570 011-MC330631 5816279 0110887709120225172702013050105816279 011-MC33230 5837430 0110840619064492172702013050105837430
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
ICU Medical, Inc.
Reason for Recall:
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 2 Check Valve, 3 Clamps, Rotating Luer;

Product Codes/Lot Numbers:

Product Numbers / Lot Numbers / UDI Codes: IR-1SF 5727531 01549878920700181724120130100105727531 IR-1S 5728008 01549878920698901724120130100105728008 IR-1SF 5737373 01549878920700181724120130100105737373 IR-1S 5738091 01549878920698901724120130100105738091 IR-1S 5755100 01549878920698901724120130100105755100 P039 5787453 0110840619063112172501013050105787453 MC33769 5664461 0110887709066844172610013050105664461 K7059-001 5692316 0110887709036977172611013050105692316 011-MC100G 5693573 01108406190790141726110130100105693573 LAT-MC100 5714006 01108877090962851726110130100105714006 LAT-MC330021 5714014 0110887709122144172611013050105714014 MC100-DC 5724498 0110887709037165172612013050105724498 MC33636 5725526 0110887709058108172612013050105725526 MC33691 5725559 0110887709064314172612013050105725559 011-MC100RR 5726283 01108406190539771726120130100105726283 011-AM3120 5726777 0110887709098876172612013025105726777 066-MC100 5735598 01108406190842231726120130100105735598 039-MC330487 5736333 0110840619098541172612013025105736333 011-H3095 5737883 0110840619043015172612013025105737883 011-MC330627 5738780 0110887709098531172612013050105738780 MC33687 5744883 0110887709064369172612013050105744883 011-MC330526 5746749 0110887709092232172612013050105746749 011-MC33428 5747264 0110840619072336172612013025105747264 011-MC33830 5747331 0110840619038578172612013025105747331 011-MC33230 5747967 0110840619064492172612013050105747967 MC33324 5753823 0110887709037738172612013025105753823 MC33467 5754104 0110887709039046172612013025105754104 MC33769 5754294 0110887709066844172612013050105754294 011-MC330164 5756448 0110840619091085172612013020105756448 011-MC33108 5757000 0110840619057838172612013050105757000 MC33688 5757503 0110887709064376172612013050105757503 011-MC33727 5758006 0110840619077713172612013050105758006 011-A1027 5759727 0110840619064676172261201350105759727 011-MC330283 5761603 0110840619092914172612013050105761603 MC33324 5762312 0110887709037738172612013025105762312 MC33687 5762576 0110887709064369172612013050105762576 MC33634 5763303 0110887709058085172701013050105763303 K7059-001 5772085 0110887709036977172701013050105772085 MC33481 5772173 0110887709051864172701013025105772173 MC33467 5772198 0110887709039046172701013025105772198 MC33769 5772352 0110887709066844172701013050105772352 011-MC33872 5772480 0110840619081284172701013050105772480 011-MC33183 5773272 0110840619061743172701013050105773272 011-MC33428 5774716 0110840619072336172701013025105774716 011-MC33474 5774726 0110840619066380172701013050105774726 011-MC5006 5775730 0110840619072657172701013025105775730 K7047-001 5777730 01108877090368541727010130100105777730 011-MC330166 5782915 0110840619090064172701013050105782915 011-MC33057 5782920 0110840619055292172701013050105782920 011-MC330631 5782922 0110887709120225172701013050105782922 011-MC33471 5782923 0110840619066212172701013050105782923 011-MC33109 5782941 0110840619057845172701013050105782941 011-MC330074 5785884 0110840619086913172701013050105785884 011-MC33473 5787377 0110840619066403172701013050105787377 011-MC33740 5788332 0110840619078154172701013025105788332 011-MC330283 5788847 0110840619092914172701013050105788847 011-MC33044 5788907 0110840619054684172701013025105788907 011-MC33474 5789113 0110840619066380172701013050105789113 011-MC330074 5797110 0110840619086913172701013050105797110 011-MC33044 5800894 0110840619054684172701013025105800894 MC33481 5800914 0110887709051864172701013025105800914 MC33634 5800955 0110887709058085172701013050105800955 011-AM3120 5801154 0110887709098876172701013025105801154 LAT-MC100 5809570 01108877090962851727020130100105809570 011-MC330631 5816279 0110887709120225172702013050105816279 011-MC33230 5837430 0110840619064492172702013050105837430

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1724-2022

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