Recall Z-0444-2007 ยท MNT Continuous, Minimal Ventilatory Support, Facility Use Ventilator
Puritan Bennett Corporation
Puritan Bennett KnightStar 330 Bi-Level Ventilator, Catalogue Numbers: Y-KS330-NA, Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD
| Date | Jan 9, 2007 (initiated Aug 31, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Mexico, Netherlan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003075 | KNIGHTSTAR 330 VENTILATOR Mallinckrodt, Inc., Dec 11, 2001 |