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U.S. Department of Health and Human Services

Class 2 Device Recall Puritan Bennett KnightStar Ventilator

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 Class 2 Device Recall Puritan Bennett KnightStar Ventilatorsee related information
Date Initiated by FirmAugust 31, 2006
Date PostedJanuary 09, 2007
Recall Status1 Terminated 3 on March 05, 2014
Recall NumberZ-0444-2007
Recall Event ID 36306
510(K)NumberK003075 
Product Classification Ventilator, Continuous, Minimum Support, Facility - Product Code MNT
ProductPuritan 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
Code Information All units are subject to this notice (all serial numbers).
Recalling Firm/
Manufacturer		 Puritan Bennett Corporation
5931 Priestly Dr Ste 100
Carlsbad CA 92008-8813
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionDomestic 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 in Commerce7,754 (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, 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MNT
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