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U.S. Department of Health and Human Services

Class 3 Device Recall Nasal Cannula Diagnostic Kit

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  Class 3 Device Recall Nasal Cannula Diagnostic Kit see related information
Date Initiated by Firm December 03, 2009
Date Posted September 19, 2010
Recall Status1 Terminated 3 on March 11, 2011
Recall Number Z-2435-2010
Recall Event ID 54668
510(K)Number K080983  
Product Classification Ventilatory Effort Recorder - Product Code MNR
Product The Provent Nasal Cannula is a nasal appliance device placed in both nostrils intended to be used for transmission of respiratory airflow signals between the Provent Professional Sleep Apnea Therapy device and physiologic recorders.
Code Information Catalog Number: MRS0208 Lot Number: 1880783
Recalling Firm/
Manufacturer		 Ventus Medical, Inc.
1301 Shoreway Rd Ste 340
Belmont CA 94002-4155
For Additional Information Contact
650-632-4165
Manufacturer Reason
for Recall		 The catalog number printed on two Nasal Cannula Diagnostic Kits (MRS0231) was different that the catalog number printed on the bulk pack shipper box and the other Nasal Cannula Kits in the same shipper (MRS0208). No devices were used on any patient .
FDA Determined
Cause 2		 Labeling mix-ups
Action Ventus Medical, Inc. of Belmont, CA has notified all customers who received distribution from the affected manufacturing lot (1880783) to immediately return the product in question for replacement. If there are any questions regarding this correction, please contact the firm at (650) 632-4165.
Quantity in Commerce 60
Distribution Product was distributed in the US through a single distribution supplier.
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 = MNR and Original Applicant = VENTUS MEDICAL, INC.
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