510(k) K223607 · FRN Pump, Infusion
Plum Duo Infusion System
| Applicant | Icu Medical, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Aug 24, 2023 |
| Received | Dec 2, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223607
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2026 | ICU Medical, Inc. ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump Open, Classified |
FRN | None listed |
| Jun 5, 2026 | ICU Medical, Inc. Plum Duo Infusion Pump, 40002-0401 Open, Classified |
FRN | None listed |
| Jan 16, 2026 | ICU Medical, Inc. ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines) Open, Classified |
FRN | None listed |
| Jan 15, 2026 | ICU Medical, Inc. Plum Duo Infusion System, List Number 40002-04-01 Open, Classified |
FRN | None listed |
| Aug 6, 2025 | ICU Medical, Inc. Plum Duo Infusion System, List Number: 400020401 Open, Classified |
FRN | None listed |
| Jun 18, 2025 | ICU Medical, Inc. ICU Medical Plum Duo, Item numbers: 1) 400020401, 2) 400021001
, and 3) 400021003; infusion pump Open, Classified |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.