Plum 360 Infusion System, List Numbers: 300100405, 300100409, 300100413, 300100414, 300100415, 300100418, 300100451, 300

FDA device recall Z-2430-2023 · posted 2023-08-18 · Open, Classified

Recall details

Recalling firm

ICU Medical Inc

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

FRN

Quantity affected

93135 devices

Distribution

Worldwide

Date initiated

2023-07-13

Date posted

2023-08-18

Location

Lake Forest, IL

Related 510(k) clearances