Recall Z-0619-2019 ยท MRZ Accessories, Pump, Infusion
ICU Medical Inc
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.
| Date | Nov 8, 2018 |
| Status | Terminated |
| Reason | There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets. |
| 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 veasna.seth@icumed.com. |
| Quantity | 31,050 units |
| Distribution | US distribution and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171346 | Sapphire Sets Icu Medical, Aug 25, 2017 |