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U.S. Department of Health and Human Services

Class 2 Device Recall RemRest NonInvasive Continuous Positive Airway Pressure System, Model 903

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  Class 2 Device Recall RemRest NonInvasive Continuous Positive Airway Pressure System, Model 903 see related information
Date Initiated by Firm September 03, 2004
Date Posted December 17, 2004
Recall Status1 Terminated 3 on August 18, 2005
Recall Number Z-0326-05
Recall Event ID 30085
510(K)Number K002763  
Product Classification Ventilator, Non-Continuous (Respirator) - Product Code BZD
Product RemRest Non-Invasive Continuous Positive Airway Pressure System, Model 903. The firm name on the device is Medical Industries America Inc., Adel, IA.
Code Information All serial numbers beginning with C0424
Recalling Firm/
Manufacturer		 Medical Industries America Inc
2636 289th Pl
Adel IA 50003-8021
For Additional Information Contact Dan Bunting
515-993-5001 Ext. 214
Manufacturer Reason
for Recall		 Units could show an error code and stop functioning.
FDA Determined
Cause 2		 Other
Action The recall was initiated via telephone on 9/3/04 to their customers explaining the reason for recall and instructing them to hold the units for further instruction. A telephone call to the customers on 9/10/04 instructed them to return the units for correction and replacement and to notify the end users.
Quantity in Commerce 74 units
Distribution Distribution was made to home health care providers located in LA, NC, NY, TX, MO, CO, IA, MA, WV, IL, and FL. Foreign distribution was made to Hong Kong, Chile, and Canada.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = BZD and Original Applicant = MEDICAL INDUSTRIES AMERICA, INC.
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