Reported Sep 21, 2022 · Ongoing
6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
ICU Medical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ICU Medical, Inc. · 951 Calle Amanecer · San Clemente, CA · 92673-6212
Is this the product you have?
- 6.5" (17 cm) Appx 0.84 ml, Smallbore Bifuse Ext Set w/2 MicroClave Clear, 2 Check Valves, Luer Lock;
- Lot codes and dates
45 of 45 products
Products covered by this recall Model / number Product as published A1009Lot Numbers: 5772700 UDI Codes: 0110887709051055172612013050105747112 A1129Lot Numbers: 5747112 UDI Code: 0110887709068190172612013050105755485 0110887709068190172701013050105772087 AC235Lot Number 5755485 5772087 UDI Code: 0110887709122069172702013050105782946 MB4V01Lot Number: 5782946 UDI Code: 0110887709079578172701013050105797658 MC330073Lot Number: 5797658 UDI Codes: 0110887709076690172612013050105724537 MC330255Lot Numbers: 5724537 UDI Codes: 0110887709081670172611013050105712884 MC3302RLot Numbers: 5712884 UDI Codes: 0110887709037271172612013050105745628 MC330362Lot Numbers: 5745628 UDI Code: 0110887709085319172701013050105772361 MC330417Lot Number: 5772361 UDI Code: 0110887709087504172701013050105782954 0110887709087504172702013050105816260 MC330476Lot Number: 5782954 5816260 UDI Codes: 0110887709090030172611013050105677797 0110887709090030172611013050105692512 0110887709090030172612013050105721748 MC330583Lot Numbers: 5677797 5692512 5721748 UDI Codes: 0110887709095868172701013050105773172 MC330611Lot Numbers: 5773172 UDI Codes: 0110887709097022172702013025105825526 0110887709097022172702013025105850314 MC330615Lot Numbers: 5825526 5850314 UDI Code: 0110887709097091172701013050105773186 0110887709097091172701013050105776699 MC33087Lot Number: 5773186 5776699 UDI Codes: 0110887709037349172612013050105732851 0110887709037349172701013050105757039 MC33092Lot Numbers: 5732851 5757039 UDI Code: 0110887709037356172612013050105757043 MC33119Lot Number: 5757043 UDI Code: 0110887709037394172611013050105692600 0110887709037394172612013050105725019 0110887709037394172701013050105777549 MC33196Lot Number: 5692600 5725019 5777549 UDI Codes: 0110887709057644172702013050105823306 MC3325Lot Numbers: 5823306 UDI Codes: 0110887709037547172611013050105679662 0110887709037547172701013050105772606 0110887709037547172701013050105772609 0110887709037547172701013050105772630 MC33290Lot Numbers: 5679662 5772606 5772609 5772630 UDI Codes: 0110887709037561172701013050105786080 0110887709037561172702013050105816255 MC33312Lot Numbers: 5786080 5816255 UDI Code: 0110887709037660172701013050105782876 0110887709037660172702013050105823287 - Amount recalled
- Total of all affected units = 5,795,989 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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