Recalls / —
—#169071
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.
- FDA product code
- MRZ — Accessories, Pump, Infusion
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K171346
- Affected lot / code info
- UDI 108877870074, All codes
Why it was recalled
There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.
Root cause (FDA determination)
Device Design
Action the firm took
On 11/08/18, Stericycle, Inc. sent a "URGENT MEDICAL DEVICE CORECTION" letter to its consignees. The letter described the product, problem and actions to be taken via traceable mailing. Delivery will be confirmed via traceable mailing. Consignees who further distributed the product were asked to notify their customers. For further inquiries, please contact ICU US Field Action Manager at 224-706-2487 or veasna.seth@icumed.com.
Recalling firm
- Firm
- ICU Medical Inc
- Address
- 600 N FIELD DRIVE, LAKE FOREST, Illinois 60045
Distribution
- Distribution pattern
- US distribution and Internationally to Canada.
Timeline
- Recall initiated
- 2018-11-08
- Terminated
- 2020-10-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #169071. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.