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.
FDA Recall Z-1033-2012 · Posted 2012-02-15
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Recalling FirmVentus Medical, Inc.
Recall StatusTerminated
Product CodeOHP
Date Initiated2012-02-03
Date Terminated2012-02-15
Product Quantity288 units
Reason for Recall
A discrepancy was found during inspection of a returned unit that the lot number and SKU on cartoon did not match.
Firm 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.
Root Cause
Labeling mix-ups
Distribution Pattern
Nationwide Distribution including the states of OH, TX, IL, OR, CA, FL and NY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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