ICU Medical 31" Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock recall: Port weld of drug transfer device may separate or break during use
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
The hazard: Device safety concern
A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
What the notice says: Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-0359-2026
- Published
- November 5, 2025
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- ICU Medical, Inc.
- Product type
- Medical devices
- Units affected
- 11000 units
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- Lot:14397353, 14418912; Distributed in Canada
Products covered by this recall
ICU Medical 31" (79 cm) Appx 3.4 ml, Admin Set w/20 Drop Integrated ChemoLock Drip Chamber, Spiros", Purple Cap, Hanger REF: CL3951
Check your product
The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- 14397353
- 14418912
Model or item number
On the rating label, the box or the instruction sheet.
- CL3951 — Lot
Package size
Match the net weight or the piece count on the front of the pack.
- 3.4 ml
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
ICU Medical, Inc. — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- If you are a facility, quarantine affected stock and log the correction.
- Report device problems to the FDA through MedWatch.
- If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
Claiming on a recalled device
Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.
- Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
- Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
- If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
- Log the date, the name and the reference number of every call. Device recalls can run for months.
Company contact: ICU Medical, Inc. — 951 Calle Amanecer, San Clemente, CA, 92673-6212
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was ICU Medical, Inc. medical devices recalled?
Port weld of drug transfer device may separate or break during use and potentially result in a leak. Port weld of drug transfer device may separate or break during use and potentially result in a leak.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: lot code 14397353, 14418912; model number CL3951 — Lot. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
Where was the recalled product sold?
It was distributed nationwide.
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