Z-0308-2012

ViroMax viral/bacterial filter. The filter reduces the risk of infection due to cross-contamination between...

Name: Z-0308-2012 ViroMax viral/bacterial filter. The filter reduces the risk of infection due to cross-contamination between...
Creator: A M Systems Inc
Published: 2010-03-31
License: https://open.fda.gov/license/

A-M Systems / initiated 2010-03-31 / Terminated / root cause: manufacturing process

FDA source

A M Systems Inc began a recall of ViroMax viral/bacterial filter. The filter reduces the risk of infection due to cross-contamination between patients For use on all patient populations in... on 2010-03-31. The reason FDA records is "Some ViroMax viral/bacterial filters are leaking at the point where the two halves of the filter are ultrasonically bonded together". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0308-2012
Status: Terminated
Initiated: 2010-03-31
Posted: 2012-01-11
Terminated: 2012-01-05
Recalling firm: A-M Systems
Product: 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.
Product code: CAH Filter, Bacterial, Breathing-Circuit
Reason for recall: Some ViroMax viral/bacterial filters are leaking at the point where the two halves of the filter are ultrasonically bonded together.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 37800
Distribution: 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.
Product codes and lots: Lot numbers: 551278, 551311, 551355, 551425, 551432, 551452, 551635, 551658, 551699, 551704, 551727, 551732, 551746, 551800, 551879, 551905, 551954 and 552095.

Product code CAH

K063526Class IIA-M Systems Viromax Viral and Bacterial FilterA-M Systems, Inc. / cleared 2007-06-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)