—#201873

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

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K141789, K161469
Affected lot / code info: UDI/DI M335300101, All Plum 360 pumps manufactured between July 2020 and December 2021

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

ICU Medical issued an URGENT: MEDICAL DEVICE CORRECTION notice on 07/13/2023 via traceable mailing. The notice explained the issue, potential risk, and requested the following: Actions for Clinical Users: If your Plum 360 pump does not power on or indicates an Audio Alarm failure, please remove the pump from use and send the pump to Biomedical Engineering. Actions for Biomedical Engineering: If you have Plum 360 pumps with Audio Alarm failures, please contact ICU Medical. 1. Locate all affected pumps in your possession and ensure all users or potential users of these devices are immediately made aware of this notification and required actions. 2. Complete and return the attached Response Form to icumedical8320@sedgwick.com within ten days of receipt to acknowledge your understanding of this notification. 3. DISTRIBUTORS: If you have distributed affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to icumedical8320@sedgwick.com. A similar notice was distributed specifically to consignees of instruments that were serviced which lists the specific serial numbers. The issue, potential risk, and actions are the same as the general notice.

Recalling firm

Firm: ICU Medical Inc
Address: 600 N Field Dr, Lake Forest, Illinois 60045-4835

Distribution

Distribution pattern: Worldwide

Timeline

Recall initiated: 2023-07-13
Posted by FDA: 2023-08-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #201873. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.