510(k) K161469 ยท FRN Pump, Infusion
Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module
| Applicant | Hospira, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Mar 28, 2017 |
| Received | May 27, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161469
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2024 | ICU Medical Inc Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010. Product description is PLUM 360 Infuser.
OUS units marketed with the following descriptions: Bomba de Open, Classified |
FRN | None listed |
| Aug 18, 2023 | ICU Medical Inc Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481, 300100483, 300100613, 300101013, 300101113, 30010 Open, Classified |
FRN | None listed |
| May 16, 2023 | ICU Medical Inc Replacement Battery List Number SUB0000864, found in Plum 360 Infusion System, List Number 30010 Open, Classified |
FRN | None listed |
| Oct 22, 2019 | ICU Medical Inc Plum 360 Infusion System With MedNet/ Smart Card Plug And Play Module, Model # 30010. Infusion pump. Terminated |
FRN | None listed |
| Oct 30, 2017 | ICU Medical Inc Plum 360 Infusion System, List number 30010. Terminated |
FRN | None listed |
| Jun 15, 2017 | ICU Medical Inc Plum 360 Infusion System Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.