Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-S
FDA device recall Z-0444-2007 · posted 2007-01-09 · Terminated
Recall details
- Recalling firm
- Puritan Bennett Corporation
- Reason for recall
- Directions for Use-Puritan Bennett has determined that a service interval should be defined for the device. The firm has also determined that an exhalation filter should be employed when the device is in use.
- Action taken
- Domestic customers of record will be advised of this matter by letter sent via Certified US Mail, Return Receipt. The letter will provide recipients with simple instructions on how they may return their units for service, and provides scheduled dates for service for each of their devices, based upon Nellcor Puritan Bennett shipment records.
- Root cause
- Other
- Status
- Terminated
- Product code
- MNT
- Quantity affected
- 7,754 (in US)
- Distribution
- Worldwide distribution ---- including USA and countries of Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Egypt,
- Date initiated
- 2006-08-31
- Date posted
- 2007-01-09
- Date terminated
- 2014-03-05
- Location
- Carlsbad, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| KNIGHTSTAR 330 VENTILATOR (K003075) | Mallinckrodt, Inc. | 2001-12-11 |