Z-0619-2019 Class II Terminated
FDA device recall Z-0619-2019 was initiated by ICU Medical Inc on Nov 8, 2018 and is designated Class II. Reason for recall: There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets. The recall status is terminated (terminated Oct 13, 2020). Affected quantity: 31,050 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 26, 2018
- Initiation Date
- Nov 8, 2018
- Termination Date
- Oct 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31,050 units
Product Description
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.
Distribution Pattern
US distribution and Internationally to Canada.
Code Information
UDI 108877870074, All codes
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0619-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026