6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Product Number: 011-MC33538 UDI Code: 0110840619072435172701013050105772700 Lot Numbers: 5772700 Product Number: A1009 UDI Codes: 0110887709051055172612013050105747112 Lot Numbers: 5747112 Product Number: A1129 UDI Code: 0110887709068190172612013050105755485 0110887709068190172701013050105772087 Lot Number 5755485 5772087 Product Number: AC235 UDI Code: 0110887709122069172702013050105782946 Lot Number: 5782946 Product Number: MB4V01 UDI Code: 0110887709079578172701013050105797658 Lot Number: 5797658 Product Number: MC330073 UDI Codes: 0110887709076690172612013050105724537 Lot Numbers: 5724537 Product Number: MC330255 UDI Codes: 0110887709081670172611013050105712884 Lot Numbers: 5712884 Product Number: MC3302R UDI Codes: 0110887709037271172612013050105745628 Lot Numbers: 5745628 Product Number: MC330362 UDI Code: 0110887709085319172701013050105772361 Lot Number: 5772361 Product Number: MC330417 UDI Code: 0110887709087504172701013050105782954 0110887709087504172702013050105816260 Lot Number: 5782954 5816260 Product Number: MC330476 UDI Codes: 0110887709090030172611013050105677797 0110887709090030172611013050105692512 0110887709090030172612013050105721748 Lot Numbers: 5677797 5692512 5721748 Product Number: MC330583 UDI Codes: 0110887709095868172701013050105773172 Lot Numbers: 5773172 Product Number: MC330611 UDI Codes: 0110887709097022172702013025105825526 0110887709097022172702013025105850314 Lot Numbers: 5825526 5850314 Product Number: MC330615 UDI Code: 0110887709097091172701013050105773186 0110887709097091172701013050105776699 Lot Number: 5773186 5776699 Product Number: MC33087 UDI Codes: 0110887709037349172612013050105732851 0110887709037349172701013050105757039 Lot Numbers: 5732851 5757039 Product Number: MC33092 UDI Code: 0110887709037356172612013050105757043 Lot Number: 5757043 Product Number: MC33119 UDI Code: 0110887709037394172611013050105692600 0110887709037394172612013050105725019 0110887709037394172701013050105777549 Lot Number: 5692600 5725019 5777549 Product Number: MC33196 UDI Codes: 0110887709057644172702013050105823306 Lot Numbers: 5823306 Product Number: MC3325 UDI Codes: 0110887709037547172611013050105679662 0110887709037547172701013050105772606 0110887709037547172701013050105772609 0110887709037547172701013050105772630 Lot Numbers: 5679662 5772606 5772609 5772630 Product Number: MC33290 UDI Codes: 0110887709037561172701013050105786080 0110887709037561172702013050105816255 Lot Numbers: 5786080 5816255 Product Number: MC33312 UDI Code: 0110887709037660172701013050105782876 0110887709037660172702013050105823287 Lot Numbers: 5782876 5823287 Product Number: MC33337 UDI Code: 0110887709037851172612013050105753046 Lot Number: 5753046 Product Number: MC33343 UDI Code: 0110887709037912172612013050105762347 Lot Number: 5762347 Product Number: MC33348 UDI Codes: 0110887709037967172612013050105753060 0110887709037967172612013050105762355 0110887709037967172701013050105789832 Lot Numbers: 5753060 5762355 5789832 Product Number: MC33409 UDI Codes: 0110887709038537172612013050105746703 0110887709038537172612013050105753968 Lot Numbers: 5746703 5753968 Product Number: MC33424 UCI Codes: 0110887709038674172701013050105778865 0110887709038674172701013050105789733 Lot Numbers: 5778865 5789733 Product Number: MC33425 UDI Codes: 0110887709038681172612013050105737011 0110887709038681172701013050105773212 0110887709038681172702013050105778871 Lot Numbers: 5737011 5773212 5778871 Product Number: MC33482 UDI Code: 0110887709039183172702013050105785919 Lot Number: 5785919 Product Number: MC33492 UDI Codes: 0110887709051871172612013050105754132 0110887709051871172701013050105772548 0110887709051871172701013050105778966 Lot Numbers: 5754132 5772548 5778966 Product Number:MC33493 UDI Code: 0110887709051888172611013050105684445 Lot Number: 5684445 Product Number: MC33547 UDI Code: 0110887709057804172612013050105753321 Lot Number: 5753321 Product Number: MC33563 UDI Codes: 0110887709057835172612013050105737877 0110887709057835172701013050105800935 Lot Numbers: 5737877 5800935 Product Number: MC33632 UDI Code: 0110887709058061172612013050105737895 Lot Number: 5737895 Product Number: MC33667 UDI Code: 0110887709062976172611013050105685338 Lot Number: 5685338 Product Number: MC33670 UDI Code: 0110887709063119172611013050105712886 Lot Number: 5712886 Product Number: MC33671 UDI Code: 0110887709063126172611013050105712863 Lot Number: 5712863 Product Number: MC33795 UDI Codes: 0110887709068046172611013050105712882 0110887709068046172701013050105778251 Lot Numbers: 5712882 5778251 Product Number: MC33917 UDI Code: 0110887709071602172612013050105757508 Lot Number: 5757508 Product Number: MC33980 UDI Codes: 0110887709075419172612013050105757494 0110887709075419172612013050105762677 Lot Numbers: 5757494 5762677 Product Number: MC33981 UDI Codes: 0110887709075426172701013050105778306 0110887709075426172701013050105800052 Lot Numbers: 5778306 5800052 Product Number: SC137 UDI Code: 0110887709040264172701013050105773207 Lot Number: 5773207 Product Number: Z3420 UDI Code: 0110887709032115172701013050105773199 Lot Number: 5773199 Product Number: Z3429 UDI Codes: 0110887709032207172612013050105749820 0110887709032207172702013050105825452 Lot Numbers: 5749820 5825452 Product Number: Z3523 UDI Code: 0110887709033082172701013050105788233 Lot Number: 5788233 Product Number: Z3574 UDI Codes: 0110887709033587172612013050105745063 0110887709033587172701013050105776728 Lot Numbers: 5745063 5776728
  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:

6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;

Product Codes/Lot Numbers:

Product Number: 011-MC33538 UDI Code: 0110840619072435172701013050105772700 Lot Numbers: 5772700 Product Number: A1009 UDI Codes: 0110887709051055172612013050105747112 Lot Numbers: 5747112 Product Number: A1129 UDI Code: 0110887709068190172612013050105755485 0110887709068190172701013050105772087 Lot Number 5755485 5772087 Product Number: AC235 UDI Code: 0110887709122069172702013050105782946 Lot Number: 5782946 Product Number: MB4V01 UDI Code: 0110887709079578172701013050105797658 Lot Number: 5797658 Product Number: MC330073 UDI Codes: 0110887709076690172612013050105724537 Lot Numbers: 5724537 Product Number: MC330255 UDI Codes: 0110887709081670172611013050105712884 Lot Numbers: 5712884 Product Number: MC3302R UDI Codes: 0110887709037271172612013050105745628 Lot Numbers: 5745628 Product Number: MC330362 UDI Code: 0110887709085319172701013050105772361 Lot Number: 5772361 Product Number: MC330417 UDI Code: 0110887709087504172701013050105782954 0110887709087504172702013050105816260 Lot Number: 5782954 5816260 Product Number: MC330476 UDI Codes: 0110887709090030172611013050105677797 0110887709090030172611013050105692512 0110887709090030172612013050105721748 Lot Numbers: 5677797 5692512 5721748 Product Number: MC330583 UDI Codes: 0110887709095868172701013050105773172 Lot Numbers: 5773172 Product Number: MC330611 UDI Codes: 0110887709097022172702013025105825526 0110887709097022172702013025105850314 Lot Numbers: 5825526 5850314 Product Number: MC330615 UDI Code: 0110887709097091172701013050105773186 0110887709097091172701013050105776699 Lot Number: 5773186 5776699 Product Number: MC33087 UDI Codes: 0110887709037349172612013050105732851 0110887709037349172701013050105757039 Lot Numbers: 5732851 5757039 Product Number: MC33092 UDI Code: 0110887709037356172612013050105757043 Lot Number: 5757043 Product Number: MC33119 UDI Code: 0110887709037394172611013050105692600 0110887709037394172612013050105725019 0110887709037394172701013050105777549 Lot Number: 5692600 5725019 5777549 Product Number: MC33196 UDI Codes: 0110887709057644172702013050105823306 Lot Numbers: 5823306 Product Number: MC3325 UDI Codes: 0110887709037547172611013050105679662 0110887709037547172701013050105772606 0110887709037547172701013050105772609 0110887709037547172701013050105772630 Lot Numbers: 5679662 5772606 5772609 5772630 Product Number: MC33290 UDI Codes: 0110887709037561172701013050105786080 0110887709037561172702013050105816255 Lot Numbers: 5786080 5816255 Product Number: MC33312 UDI Code: 0110887709037660172701013050105782876 0110887709037660172702013050105823287 Lot Numbers: 5782876 5823287 Product Number: MC33337 UDI Code: 0110887709037851172612013050105753046 Lot Number: 5753046 Product Number: MC33343 UDI Code: 0110887709037912172612013050105762347 Lot Number: 5762347 Product Number: MC33348 UDI Codes: 0110887709037967172612013050105753060 0110887709037967172612013050105762355 0110887709037967172701013050105789832 Lot Numbers: 5753060 5762355 5789832 Product Number: MC33409 UDI Codes: 0110887709038537172612013050105746703 0110887709038537172612013050105753968 Lot Numbers: 5746703 5753968 Product Number: MC33424 UCI Codes: 0110887709038674172701013050105778865 0110887709038674172701013050105789733 Lot Numbers: 5778865 5789733 Product Number: MC33425 UDI Codes: 0110887709038681172612013050105737011 0110887709038681172701013050105773212 0110887709038681172702013050105778871 Lot Numbers: 5737011 5773212 5778871 Product Number: MC33482 UDI Code: 0110887709039183172702013050105785919 Lot Number: 5785919 Product Number: MC33492 UDI Codes: 0110887709051871172612013050105754132 0110887709051871172701013050105772548 0110887709051871172701013050105778966 Lot Numbers: 5754132 5772548 5778966 Product Number:MC33493 UDI Code: 0110887709051888172611013050105684445 Lot Number: 5684445 Product Number: MC33547 UDI Code: 0110887709057804172612013050105753321 Lot Number: 5753321 Product Number: MC33563 UDI Codes: 0110887709057835172612013050105737877 0110887709057835172701013050105800935 Lot Numbers: 5737877 5800935 Product Number: MC33632 UDI Code: 0110887709058061172612013050105737895 Lot Number: 5737895 Product Number: MC33667 UDI Code: 0110887709062976172611013050105685338 Lot Number: 5685338 Product Number: MC33670 UDI Code: 0110887709063119172611013050105712886 Lot Number: 5712886 Product Number: MC33671 UDI Code: 0110887709063126172611013050105712863 Lot Number: 5712863 Product Number: MC33795 UDI Codes: 0110887709068046172611013050105712882 0110887709068046172701013050105778251 Lot Numbers: 5712882 5778251 Product Number: MC33917 UDI Code: 0110887709071602172612013050105757508 Lot Number: 5757508 Product Number: MC33980 UDI Codes: 0110887709075419172612013050105757494 0110887709075419172612013050105762677 Lot Numbers: 5757494 5762677 Product Number: MC33981 UDI Codes: 0110887709075426172701013050105778306 0110887709075426172701013050105800052 Lot Numbers: 5778306 5800052 Product Number: SC137 UDI Code: 0110887709040264172701013050105773207 Lot Number: 5773207 Product Number: Z3420 UDI Code: 0110887709032115172701013050105773199 Lot Number: 5773199 Product Number: Z3429 UDI Codes: 0110887709032207172612013050105749820 0110887709032207172702013050105825452 Lot Numbers: 5749820 5825452 Product Number: Z3523 UDI Code: 0110887709033082172701013050105788233 Lot Number: 5788233 Product Number: Z3574 UDI Codes: 0110887709033587172612013050105745063 0110887709033587172701013050105776728 Lot Numbers: 5745063 5776728

Distribution:

Nationwide distribution

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1721-2022

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