Breath Tech, Safe Spot Infant Resuscitator, BT2000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce D
FDA device recall Z-0174-2013 · posted 2012-11-01 · Terminated
Recall details
- Recalling firm
- Ventlab Corporation
- Reason for recall
- Possible volume leakage through the inlet valve during compressions of the resuscitator bag.
- Action taken
- VentLab Corporation sent an Attention: Recall Notification letter dated July 10, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for the affected product, complete and return the enclosed response form by fax to 336-753-5002, indicating whether or not their facility has any of the affected product. Customers can also scan and email the response form to CSR@Ventlab.com. For questions regarding this recall call 336-753-5000.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- BTM
- Quantity affected
- 14,602 total for all units
- Distribution
- Nationwide Distribution including IL, OH, NY and TN.
- Date initiated
- 2012-07-11
- Date posted
- 2012-11-01
- Date terminated
- 2013-06-30
- Location
- Mocksville, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| V*CARE MANUAL RESUSCITATOR (K012842) | Ventlab Corp. | 2001-09-18 |