Lower riskMedical device recall · FDA · Published November 8, 2018
ICU Medical Sapphire Epidural Set: Distal Occlusion Alarms Recalled
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.
“ICU Medical Sapphire Epidural Set: Distal Occlusion Alarms Recalled.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69488-icu-medical-sapphire-epidural-set-distal-occlusion-alarms-recalled. Based on FDA recall #Z-0619-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0619-2019%22&limit=1).
ICU Medical, Inc. voluntarily recalled SAPPHIRE Epidural Sets due to reports of distal occlusion alarms during use, the FDA said on November 8, 2018. The recall involves 31,050 units distributed in the U.S. and Canada.
How to tell if you have it
Brand: ICU Medical
Product: SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch
List Number: 16373-02 Sapphire
UDI: 108877870074
The hazard
There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets, according to the FDA. The record does not report specific incidents or injuries.
Context
GovInfoNow's records show ICU Medical, Inc. has 60 other recalls on record since June 15, 2017. Other recent recalls of similar products include ICU Medical CADD Yellow Medication Cassette Reservoir Recall (August 20, 2026), ICU Medical Hotline Fluid Warming Set Recall (June 24, 2026), and B. Braun Medical NES1725KFXL Spinal Epidural Catheter Recall (January 29, 2026).
How to tell if you have this one
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.
Brand
ICU Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify if your set has the Yellow-Striped Microbore, 0.2 micron filter, PAV, 123-inch length, and List Number 16373-02.
How this recall unfolded
Recall timeline
FDA terminated this recall 23 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0619-2019 (November 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0619-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.