SAPPHIRE Epidural Set Yellow-Striped Microbore — Class II medical device recall Z-0619-2019
Terminated recall by ICU Medical Inc, reported 2018-12-26. There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped admi
| Recall number | Z-0619-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical Inc, LAKE FOREST, IL, United States |
| Recall initiated | 2018-11-08 |
| Classified | 2018-12-17 |
| Reported by FDA | 2018-12-26 |
| Terminated | 2020-10-13 |
| Countries outside the US | CA |
| Quantity | 31,050 units |
| Reason classes | device malfunction |
Product
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.
Reason for recall
There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0619-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.