CLASS II Device recall · Reported 26 Dec 2018 · FDA Enforcement Report

Sapphire Epidural Set Yellow-Striped Microbore recalled by ICU Medical

ICU Medical is recalling Sapphire Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, List Number. The recall was initiated on 8 Nov 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI 108877870074, All codes

Quantity recalled31,050 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-0619-2019
FDA event ID: 81615
Recalling firm: ICU Medical, LAKE FOREST, IL
Classification: Class II
Status: Terminated
Recall initiated: 8 Nov 2018
FDA classified: 17 Dec 2018
Reported: 26 Dec 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

8 Nov 2018	Recall initiated by company
17 Dec 2018	Classified by FDA	+39 days
26 Dec 2018	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

There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.

Where it was distributed

US distribution and Internationally to Canada.

Questions about this recall

Why was it recalled?

There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.

Which lots are affected?

UDI 108877870074, All codes

Where was it sold?

US distribution and Internationally to Canada.

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 26 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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