ViroMax viral/bacterial filter. The filter reduces the risk of infection due to cross-contamination between patients For use on all patient populations in conjunction with other respiratory devices containing standard 15mm and/or 22mm fittings (such as breathing circuits) to filter respiratory gases where infection from airborne bacteria and viruses is a concern. Disposable, for single patient use only.
FDA Recall Z-0308-2012 · Posted 2012-01-11
Recalling FirmA M Systems Inc
Recall StatusTerminated
Product CodeCAH
Date Initiated2010-03-31
Date Terminated2012-01-05
Product Quantity37800
Reason for Recall
Some ViroMax viral/bacterial filters are leaking at the point where the two halves of the filter are ultrasonically bonded together.
Firm Action
A - M Systems sent a Urgent Notification of Product Recall/Correction dated March 31, 2010, to all affected customers. The letter identificed the product the problem and the action needed to be taken by the customer.
Customers were instructed to cease use and/or distribution of the affected product and to immediately notify any of their sub-accounts with the same information. Customers are asked to provide A - M Systems with the amount distributed and amount remaining in inventory and to then destroy or discard any remaining product in their possession.
Please call 360.683.8300, if you have any questions or concerns.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide Distribution -- USA ( nationwide) including the states of AZ, CA, FL, KY, MA, MI, NC, OH, OR, and WI., and the countries Canada, Mexico, and Taiwan.
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.