FDA Recall Terminated

Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and institutional settings and is not intended for ambulance or air transport.

Recall: Z-0484-2021 · Initiated November 12, 2020

Recall

Recall Number
Z-0484-2021
Event Number
86756
Firm
Hill-Rom Manufacturing, Inc.
FEI Number
2183816
Product Code
CBK
Status
Terminated
Root Cause
Process control
Initiated
November 12, 2020
Terminated
November 10, 2022
Address
1020 County Road F W, Saint Paul, MN, 55126-2910

Description

Life2000 Ventilation System, including Life2000 Ventilator and Life2000 Compressor, Model MS-01-0118 - Product Usage: use in home and institutional settings and is not intended for ambulance or air transport.

Reason

Under certain conditions, there is a risk for fire.

Action

The recalling firm is contacting all impacted consignees to notify of the recall. A response form is included with the customer notification. Consignees are requested to return the response form as proof of receipt of the mailing. Phone call follow-ups will commence if a response form is not received in a timely manner. A Hillrom representative will be contacting patients to schedule a time to come to your home to deliver a new Life2000 Ventilator to you and return your current device to Hillrom. Should you hear an audible hissing sound inside of the ventilator, this may indicate a gas leak inside ventilator. If you hear the audible hissing described, please discontinue use and contact Hillrom Customer Service immediately.

Distribution

US Nationwide distribution including in the states of AR, AZ, CA, DE, FL, IL, IN, KY, MN, NC, NM, NV, NY, OH, OK, TX, UT, VA, VT, WI.

Quantity

67 devices