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U.S. Department of Health and Human Services

Class 2 Device Recall Compella

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  Class 2 Device Recall Compella see related information
Date Initiated by Firm February 14, 2022
Create Date March 23, 2022
Recall Status1 Open3, Classified
Recall Number Z-0821-2022
Recall Event ID 89644
Product Classification Bed, flotation therapy, powered - Product Code IOQ
Product Compella Therapy Air Supply Unit
Code Information All lots/serial numbers UDI information: Compella Therapy Air Supply Unit - 00887761013803
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
Manufacturer Reason
for Recall		 Potential damage to the power cord may cause the power conductors to be exposed, thereby creating a risk of shock from the power mains.
FDA Determined
Cause 2		 Labeling design
Action Customer notification letters were mailed beginning 02/21/2022. A localized customer letter will be mailed (with signature service) to all first-level consignees by Sedgwick. The letter will inform the customer of the issue, reason for Field Action and provide risk mitigations. The customer will be instructed to sign acknowledgement form to confirm receipt and return to a dedicated email address. Distributors will be asked to forward to their end users. Distributors will be provided with instructions on communication with their end users. All consignees will be required to return a signed acknowledgment form and confirm that they read and understand the issue. Distributors will be asked to forward to their end users. Distributors will be provided instruction on communication with their end users.
Quantity in Commerce 6022 units
Distribution Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahamas, Bahrain, Belgium, Bermuda, Brazil, Cameroon, Canada, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Jamaica, Jordan, Kuwait, Mexico, Netherlands, New Zealand, Norway, Oman, Poland, Qatar, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, Turkmenistan, UAE, and UK.
Total Product Life Cycle TPLC Device Report
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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