CLASS II Device recall · Reported 18 Apr 2018 · FDA Enforcement Report

5" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector recalled

ICU Medical is recalling 5" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50, distributed nationwide in the US. The recall was initiated on 5 Feb 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot number 3549002, UDI 01) 0 0887709 01857 0 (17) 221001 (30) 01 (10) 3549002.

Quantity recalled100 pouches

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-1346-2018
FDA event ID: 79077
Recalling firm: ICU Medical, San Clemente, CA
Classification: Class II
Status: Terminated
Recall initiated: 5 Feb 2018
FDA classified: 10 Apr 2018
Reported: 18 Apr 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Heart & Vascular Devices

Timeline

5 Feb 2018	Recall initiated by company
10 Apr 2018	Classified by FDA	+64 days
18 Apr 2018	Published in enforcement report	+8 days

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

Reason for recall

The infusion sets were manufactured with an incorrect spin collar.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

5" (13 cm) Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 pouches per case, Item B99066, Sterile, Rx. The firm name on the label is icumedical, San Clemente, CA. The Intravascular Administration Set is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or catheter (which is inserted into a vein).

Where it was distributed

Worldwide Distribution: US (nationwide) to state in AZ, CA, CO, FL, SC, and TX; and countries of: Canada and Japan.

Nationwide Arizona California Colorado Florida South Carolina Texas

Questions about this recall

Is 5" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 recalled?

Yes. ICU Medical recalled 5" Smallbore Ext Set w/MicroClave¿, Clave¿ T-Connector, Clamp, Rotating Luer, 50 on 5 Feb 2018. The recall is Class II and its status is Terminated. Recall number Z-1346-2018.

Why was it recalled?

The infusion sets were manufactured with an incorrect spin collar.

Which lots are affected?

Lot number 3549002, UDI 01) 0 0887709 01857 0 (17) 221001 (30) 01 (10) 3549002.

Where was it sold?

Worldwide Distribution: US (nationwide) to state in AZ, CA, CO, FL, SC, and TX; and countries of: Canada and Japan.

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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