510(k) K171346 ยท MRZ Accessories, Pump, Infusion
Sapphire Sets
| Applicant | Icu Medical, Lake Forest IL, US |
| Decision | Substantially Equivalent, Aug 25, 2017 |
| Received | May 8, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171346
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Microbore, 122 Inch. 1 unit per pouch; 50 pouch Terminated |
FRN | None listed |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set, Microbore, CLAVE Y-Site, 118 Inch. 1 unit per Terminated |
MRZ | None listed |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 119 Inch. 1 unit per Terminated |
FRN | None listed |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. 1 uni Terminated |
FRN | None listed |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inc Terminated |
FRN | None listed |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit pe Terminated |
FRN | None listed |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter 1 Terminated |
FRN | None listed |
| Jul 29, 2019 | ICU Medical Inc Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set with NRFit Connector Yellow-Striped Microbore, 0.2 Micron Filter, Terminated |
MRZ | None listed |
| Nov 8, 2018 | 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 Terminated |
MRZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.