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U.S. Department of Health and Human Services

Class 2 Device Recall SAPPHIRE Epidural Set YellowStriped Microbore

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  Class 2 Device Recall SAPPHIRE Epidural Set YellowStriped Microbore see related information
Date Initiated by Firm November 08, 2018
Create Date December 17, 2018
Recall Status1 Terminated 3 on October 13, 2020
Recall Number Z-0619-2019
Recall Event ID 81615
510(K)Number K171346  
Product Classification Accessories, pump, infusion - Product Code MRZ
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.
Code Information UDI 108877870074, All codes
Recalling Firm/
Manufacturer		 ICU Medical Inc
600 N FIELD DRIVE
LAKE FOREST IL 60045
For Additional Information Contact customer care
877-946-7747
Manufacturer Reason
for Recall		 There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.
FDA Determined
Cause 2		 Device Design
Action 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.
Quantity in Commerce 31,050 units
Distribution US distribution and Internationally to Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MRZ and Original Applicant = ICU Medical
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