Date Initiated by Firm | February 03, 2012 |
Date Posted | February 15, 2012 |
Recall Status1 |
Terminated 3 on February 15, 2012 |
Recall Number | Z-1033-2012 |
Recall Event ID |
61129 |
510(K)Number | K090398 |
Product Classification |
Expiratory resistance valve, intranasal, for obstructive sleep apnea - Product Code OHP
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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 CA 94002-4154
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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 | 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 |
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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 = OHP
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