Reported Dec 30, 2020 · Ongoing
31" (78 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Bag Hanger, REF: 011-CL3011;…
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 of 6 products
| Model / number | Product as published |
|---|---|
011-CL3011 | 40" (102 cm) Appx 4.9 ml, Admin Set w/ChemoLock, 20 Drop In-Line Drip Chamber, Spiros, Bag Hanger |
011-CL3020 | ChemoLock Port w/Spiros, Red Cap |
CL-35 | 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros, Purple Cap, Hanger |
CL3951 | 40" (102 cm) Appx 7.7 ml, Admin Set w/ChemoLock w/Red Cap, 20 Drop In-Line Drip Chamber, 0.2 Micron Filter, Spiros w/Red Cap, Bag Hanger |
CL3962 | 31" (79 cm) Appx 3.5 ml, Admin Set w/ChemoLock Bag Spike with Additive Port, 20 Drop In-Line Chamber w/15 Micron Filter, Spiros, Purple Cap, Hanger |
CL3999 | — |
- Lot codes and dates
- Lots
48679374751234479926248947894787230486794748970754720480473568447584564775068479450448600434799897478723448080454860044
- Lots
- Amount recalled
- 88700
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Where it was sold
Why it was recalled
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
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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