Reported Sep 21, 2022 · Ongoing
8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps,…
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?
- 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psig) Ext Set w/2 Remv MicroClave Clear, 2 Purple Clamps, Rotating Luer;
- Lot codes and dates
18 of 18 products
Products covered by this recall Model / number Product as published A1099Lot Numbers: 5735675 5755784 5755788 5812525 UDI Codes: 0110887709053127172611013050105692378 A1129Lot Numbers: 5692378 UDI Code: 0110887709068190172612013050105755485 0110887709068190172701013050105772087 A1132Lot Number 5755485 5772087 UDI Code: 0110887709068350172701013050105772482 A1152Lot Number: 5772482 UDI Code: 0110887709071527172612013050105735432 0110887709071527172701013050105787700 MC330113Lot Number: 5735432 5787700 UDI Codes: 0110887709078120172612013050105746371 0110887709078120172612013050105755711 0110887709078120172701013050105789359 MC330246Lot Numbers: 5746371 5755711 5789359 UDI Codes: 0110887709081502172610013050105641882 0110887709081502172612013050105738474 0110887709081502172701013050105773798 0110887709081502172701013050105788509 0110887709081502172701013050105809713 MC330247Lot Numbers: 5641882 5738474 5773798 5788509 5809713 UDI Codes: 0110887709081519172612013050105745619 0110887709081519172612013050105756766 0110887709081519172701013050105777168 0110887709081519172701013050105789411 MC33056Lot Numbers: 5745619 5756766 5777168 5789411 UDI Code: 0110887709037301172701013050105772683 MC330605Lot Number: 5772683 UDI Code: 0110887709097008172701013050105789539 MC33122Lot Number: 5789539 UDI Codes: 0110887709037400172612013050105757061 0110887709037400172701013050105772640 0110887709037400172701013050105788745 MC33213Lot Numbers: 5757061 5772640 5788745 UDI Codes: 0110887709037516172612013050105736601 0110887709037516172701013050105789780 0110887709037516172701013050105789784 MC33326Lot Numbers: 5736601 5789780 5789784 UDI Codes: 0110887709037752172612013050105757376 0110887709037752172701013050105772627 0110887709037752172701013050105772638 0110887709037752172702013050105810377 MC33600Lot Numbers: 5757376 5772627 5772638 5810377 UDI Code: 0110887709051932172701013050105789950 MC33729Lot Number: 5789950 UDI Codes: 0110887709065045172701013050105789984 0110887709065045172701013050105800993 MC33786Lot Numbers: 5789984 5800993 UDI Code: 0110887709067551172701013050105778247 Z3419Lot Number: 5778247 UDI Code: 0110887709032108172612013050105754551 Z3678Lot Number: 5754551 UDI Codes: 0110887709034607172612013050105754702 0110887709034607172701013050105777801 — Lot Numbers: 5754702 5777801 - 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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