Recall Z-3031-2017— ICU Medical Inc
Class II · Terminated
Class II FDA medical device recall by ICU Medical Inc, initiated 2017-06-15, terminated 2020-04-17. It names 2 FDA 510(k) clearances: K161469, K141789. Product: Plum 360 Infusion System. Reason: Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therapy or interrupt an infusion..
- Recalling firm
- ICU Medical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-06-15
- Terminated
- 2020-04-17
- 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
Reason for recall
Potential for the Connectivity Engine Module of the affected unit to disengage from the main chassis, causing the unit to shut down without an alarm notification. This would delay initiation of therapy or interrupt an infusion.
Data sourced from openFDA. This site is unofficial and independent of the FDA.