ICU Medical recalls Yellow-Striped Microbore Epidural Sets with 0.2 micron filters due to reported distal occlusion alarms during use. Affected units may have distal occlusion alarms.
There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.
ICU Medical is recalling Yellow-Striped Microbore Epidural Sets with 0.2 micron filters because they've reported distal occlusion alarms during use. This could lead to improper medication delivery if the alarm isn't functioning correctly.
The sets have reported distal occlusion alarms, which may indicate a blockage in the delivery system. This could lead to improper medication delivery if the alarm isn't functioning correctly.
Healthcare professionals using these epidural sets for patient medication delivery. Patients receiving epidural treatments with these sets are at risk if alarms malfunction.
Check for the Yellow-Striped Microbore Epidural Set with 0.2 micron filter, PAV, 123-inch length, and List Number 16373-02. These sets were sold with the UDI 108877870074.
Identify if your set has the Yellow-Striped Microbore, 0.2 micron filter, PAV, 123-inch length, and List Number 16373-02.
There have been reports of distal occlusion alarms during use of these sets, which could indicate a blockage in the delivery system.
Check for the Yellow-Striped Microbore Epidural Set with 0.2 micron filter, PAV, 123-inch length, and List Number 16373-02.
The recall does not specify a remedy, so contact ICU Medical for further instructions.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-0619-2019 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-0619-2019 from ICU Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
