Provent -SR - Sleep Apnea Therapy-SR (standard resistance). Prescription only, Single Use; Packed 30 units per box Manuf
FDA device recall Z-1033-2012 · posted 2012-02-15 · Terminated
Recall details
- Recalling firm
- Ventus Medical, Inc.
- 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 taken
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- OHP
- Quantity affected
- 288 units
- Distribution
- Nationwide Distribution including the states of OH, TX, IL, OR, CA, FL and NY.
- Date initiated
- 2012-02-03
- Date posted
- 2012-02-15
- Date terminated
- 2012-02-15
- Location
- Belmont, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PROVENT PROFESSIONAL SLEEP APNEA THERAPY (K090398) | Ventus Medical, Inc. | 2009-04-03 |