Recall Z-2430-2023— ICU Medical Inc
Class II · Ongoing
Class II FDA medical device recall by ICU Medical Inc, initiated 2023-07-13. It names 2 FDA 510(k) clearances: K161469, K141789. Product: Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481, 300100483, 300100613, 300101013, 300101113, 300101114, 300101313, 300101379, 300102213, 300102713, 300102913, 300103413, 300103414, 300104213, 300105413, 300105713, 300106313, 300106513, 300106581, 300107813, 300107814, 300108513, 300108813, 300108814, 300109913; infusion pump. Reason: Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions..
- Recalling firm
- ICU Medical Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-07-13
- Firm location
- Lake Forest, IL, United States
510(k) clearances named in this recall
2 on FDA's record- K161469 — Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module
- K141789 — PLUM 360 INFUSION SYSTEM WITH HOSPIRA MEDNET, SMART CARD PLUG N PLAY CE 3.0 MODULE FOR PLUM A+ INFUSION SYSTEM UPGRADE
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300100452, 300100453, 300100481, 300100483, 300100613, 300101013, 300101113, 300101114, 300101313, 300101379, 300102213, 300102713, 300102913, 300103413, 300103414, 300104213, 300105413, 300105713, 300106313, 300106513, 300106581, 300107813, 300107814, 300108513, 300108813, 300108814, 300109913; infusion pump
Reason for recall
Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.
Data sourced from openFDA. This site is unofficial and independent of the FDA.