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
FDA Recall Z-0444-2007 · Posted 2007-01-09
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Recalling FirmPuritan Bennett Corporation
Recall StatusTerminated
Product CodeMNT
Date Initiated2006-08-31
Date Terminated2014-03-05
Product Quantity7,754 (in US)
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.
Firm 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.
Root Cause
Other
Distribution Pattern
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, Netherlands, Norway, Poland, Portugal, Peru, Puerto Rico, Russia, Saudi Arabia, Scotland, Serbia & Montenegro, Singapore, Slovak Republic, South Africa, Spain, Switzerland, Syria, Turkey, United Arab Emirates, United Kingdom and Venezuela.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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