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 Recall Z-0619-2019 · Posted None
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Recalling FirmICU Medical Inc
Recall StatusTerminated
Product CodeMRZ
Date Initiated2018-11-08
Date Terminated2020-10-13
Product Quantity31,050 units
Reason for Recall
There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.
Firm 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 [email protected].
Root Cause
Device Design
Distribution Pattern
US distribution and Internationally to Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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