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 |
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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.
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510(K) Database | 510(K)s with Product Code = MRZ
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