CLASS II ONGOING Device recall · Reported 5 Nov 2025 · FDA Enforcement Report

73" Appx, Ext Set, Smallbore w/ChemoLock Port, Clamp recalled

ICU Medical is recalling ICU Medical 73" Appx, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap, distributed nationwide in the US. The recall was initiated on 8 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI:10887709123356/Lot: 14332784

Quantity recalled200 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0340-2026
FDA event ID: 97583
Recalling firm: ICU Medical, San Clemente, CA
Classification: Class II
Status: Ongoing
Recall initiated: 8 Sep 2025
FDA classified: 27 Oct 2025
Reported: 5 Nov 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

8 Sep 2025	Recall initiated by company
27 Oct 2025	Classified by FDA	+49 days
5 Nov 2025	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

ICU Medical 73" (185 cm) Appx 2.5 ml, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap REF: CL4176

Where it was distributed

Worldwide distribution: US (Nationwide) including states of: AK AL AR AZ CA CO CT DE FL GA IA ID IL KS KY LA MA MD MI MN MS MT NC NE NJ NM NV NY OH OK OR PA SD TN TX VA WA WY and OUS (foreign) to countries of: Canada, France, and Japan.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Connecticut Florida Georgia Iowa Illinois Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Mississippi Montana

Questions about this recall

Is 73" Appx, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap recalled?

Yes. ICU Medical recalled 73" Appx, Ext Set, Smallbore w/ChemoLock Port, Clamp, ChemoLock w/Red Cap on 8 Sep 2025. The recall is Class II and its status is Ongoing. Recall number Z-0340-2026.

Why was it recalled?

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

Which lots are affected?

UDI:10887709123356/Lot: 14332784

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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