Z-0619-2019Class II

SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02...

Name: Z-0619-2019 SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02...
Creator: ICU Medical Inc
Published: 2018-11-08
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-11-08 / Terminated / root cause: design

FDA source

ICU Medical Inc began a recall of 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... on 2018-11-08. FDA classified it as Class II and gives the reason as "There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0619-2019
Classification: Class II
Status: Terminated
Initiated: 2018-11-08
Posted: 2018-12-17
Terminated: 2020-10-13
Recalling firm: Abbott Medical
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.
Product code: MRZ Accessories, Pump, Infusion
Reason for recall: There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.
Root cause tag: design
FDA root cause: 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 [email protected].
Quantity in commerce: 31,050 units
Distribution: US distribution and Internationally to Canada.
Product codes and lots: UDI 108877870074, All codes

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0619-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0619-2019	Class II	Terminated	Voluntary: Firm initiated	2018-12-26	2018-12-17

Product code MRZ

K171346Class IISapphire SetsIcu Medical / cleared 2017-08-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)