Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall DeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylindersee related information
Date Initiated by FirmJanuary 24, 2007
Date PostedApril 21, 2007
Recall Status1 Terminated 3 on August 27, 2009
Recall NumberZ-0731-2007
Recall Event ID 37189
510(K)NumberK020329 
Product Classification Oxygen cylinders - Product Code NFB
ProductDeVilbiss PD1000A Pulse Dose Oxygen Conserving Cylinder
Code Information Model PD1000A-M4, serial numbers 06AM4111006 through 06AM4111055; Model PD1000A-M6, serial numbers 06AM6111008 through 06AM6114328; Model PD1000A-ML6, serial numbers 06AML111006 through 06AML111922; Model PD1000A-C, serial numbers 06AC0111001 through 06AC0111191; Model PD1000A-D, serial numbers 06AD0111011 through 06AD0111132; and Model PD1000A-E, serial numbers 06AE0111006-06AE0111267.
FEI Number 2515872
Recalling Firm/
Manufacturer		 Sunrise Medical
100 Devilbiss Dr
Somerset PA 15501-2125
For Additional Information ContactJoseph E. Olsavsky
814-443-7690
Manufacturer Reason
for Recall		Cylinder could lose oxygen at high pressure after the filling process
FDA Determined
Cause 2		Other
ActionThe recalling firm began to notify customer via telephone on 1/24/07. An ''Urgent Medical Device Recall Letter'' was sent on 1/29/07. Customers were advised what model and serial numbers were affected and how to contact the firm and/or dealer to have the unit replaced. The recalling firm identified additional serial numbers that were involved in the recall therefore another Urgent Medical Device Recall Letter dated 6/12/07 was sent to the customers that received the addiitonal units.
Quantity in Commerce4,169 units (Z-0731/0732-2007)
DistributionWorldwide-original shipments to distributors/dealers USA and Canada.
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 = NFB
-
-