| | Class 3 Recall
Provent-SR or Provent-50 |  |
| Date Posted |
February 15, 2012 |
| Recall Number |
Z-1033-2012 |
| 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
|
Reason for
Recall |
A discrepancy was found during inspection of a returned unit that the lot number and SKU on cartoon did not match.
|
| 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. |
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