ViroMax viral/bacterial filter. The filter reduces the risk of infection due to cross-contamination between patients For
FDA device recall Z-0308-2012 · posted 2012-01-11 · Terminated
Recall details
- Recalling firm
- A M Systems Inc
- Reason for recall
- Some ViroMax viral/bacterial filters are leaking at the point where the two halves of the filter are ultrasonically bonded together.
- Action taken
- 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
- Status
- Terminated
- Product code
- CAH
- Quantity affected
- 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.
- Date initiated
- 2010-03-31
- Date posted
- 2012-01-11
- Date terminated
- 2012-01-05
- Location
- Sequim, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| A-M SYSTEMS VIROMAX VIRAL AND BACTERIAL FILTER (K063526) | A-M Systems, Inc. | 2007-06-29 |