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U.S. Department of Health and Human Services

Class 3 Device Recall ProventSR or Provent50

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 Class 3 Recall
ProventSR or Provent50
see related information
Date Posted February 15, 2012
Recall Status1 Terminated on February 15, 2012
Recall Number Z-1033-2012
Recall Event ID 61129
Premarket Notification
510(K) Number
K090398 
Product Classification Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea - Product Code OHP
Product Provent -SR - Sleep Apnea Therapy-SR (standard resistance). Prescription only, Single Use; Packed 30 units per box Manufactured in the USA by Ventus Medical Inc. 1301 Shoreway Road, Suite 425; Belmont, CA 94002 Used in the treatment of obstructive sleep apnea.
Code Information Catalog number MRS0227; Lot number: 14261182.
Recalling Firm/
Manufacturer
Ventus Medical, Inc.
1301 Shoreway Rd Ste 425
Belmont, California 94002-4154
For Additional Information Contact Michael Nevares
650-632-4189
Manufacturer Reason
for Recall
A discrepancy was found during inspection of a returned unit that the lot number and SKU on cartoon did not match.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Ventus Medical sent a Urgent Medical Device Correction Letter dated February 3, 2012, to all affected customers. The letter identified the problem, the product and the action needed to be taken by the customer. There is no health hazard associated with the affected devices or with the continued use of the affected devices. Ventus Medical wanted Customers to be aware of the problem so they can respond to patients if inquiries are received. A sample letter to patients was also provided, should physicians choose to provide it to patients. Questions may be directed to Ventus Medical Territory Business Manager at 650-632-4199.
Quantity in Commerce 288 units
Distribution Nationwide Distribution including the states of OH, TX, IL, OR, CA, FL and NY.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OHP and Original Applicant = VENTUS MEDICAL, INC.
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