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Class 2 Device Recall Life2000 Ventilation System |
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Date Initiated by Firm |
November 12, 2020 |
Create Date |
November 24, 2020 |
Recall Status1 |
Terminated 3 on November 10, 2022 |
Recall Number |
Z-0484-2021 |
Recall Event ID |
86756 |
510(K)Number |
K170037
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Product Classification |
Ventilator, continuous, facility use - Product Code CBK
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Product |
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. |
Code Information |
Devices with the following Serial Numbers: 120210000731, L2004034-154, 120210000716, L1905010-080, 120210000750, 120190000086, 120190001268, 120210000885, 120190000724, 120190001234 120190001276, 120210000732, L1911019-029, 120210000761, L2002011-094, 120210000747, 120210000760, 120210000730, 120210000734, 120190000076 120190000079, 120190000081, 120190000090, 120190000714, 120190000722, 120190000074, 120190000077, 120190000728, 120210001608, 120210000742, 120210000755, L2001006-040, 120210000733 L1911019-035, 120210000744, 120210001613, 120210001614, 120210000714 L1903102-021, 120190001269, 120210000743, 120210000741, L1912010-015, 120210000753, 120210000739, 120190000088, 120190000711, 120190000718 120190001264, 120210001615, L1903102-012, L2001016-045, 120190000078 120190000089, 120190001266, 120210000884, 120190000091, 120190000093, 120190000707, 120210000729, L1903103-006, L1912010-005 L1912013-033, L2002040-095, L2002040-064, L2002040-093, L2003004-106 |
Recalling Firm/ Manufacturer |
Hill-Rom Manufacturing, Inc. 1020 County Road F W Saint Paul MN 55126-2910
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For Additional Information Contact |
Hillrom Technical Support 800-426-4224
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Manufacturer Reason for Recall |
Under certain conditions, there is a risk for fire.
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FDA Determined Cause 2 |
Process control |
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. |
Quantity in Commerce |
67 devices |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = CBK and Original Applicant = Breathe Technologies
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