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U.S. Department of Health and Human Services

Class 2 Device Recall Smiths Medical OxyPEEP High Flow O2 with PEEP

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  Class 2 Device Recall Smiths Medical OxyPEEP High Flow O2 with PEEP see related information
Date Initiated by Firm March 04, 2008
Date Posted July 16, 2008
Recall Status1 Terminated 3 on August 20, 2012
Recall Number Z-1380-2008
Recall Event ID 46947
510(K)Number K854822  
Product Classification Positive End Expiratory Pressure Attachment Breathing - Product Code BYE
Product Smiths Medical Oxy-PEEP High Flow O2 with PEEP; Positive end expiratory pressure breathing attachment; Reference Number: P63000; Smiths Medical, Rockland, MA 02370.
Code Information Lot Numbers: 38A30D064 and 38B09D021
Recalling Firm/
Manufacturer		 Smiths Medical ASD, Inc.
160 Weymouth St
Rockland MA 02370-1136
For Additional Information Contact
678-878-8011
Manufacturer Reason
for Recall		 Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due to incorrectly molded part. Patient will not receive proper amounts of air/oxygen when in need.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were notified on 2/26/08 via telephone to place the affected products on hold pending further instruction from the recalling firm. A follow-up letter was issued on 3/4/08 advising consignees to return any product in stock for a replacement or credit. Distributors were requested to provide their customer lists to the recalling firm in order to notify their customers of this recall.
Quantity in Commerce 196
Distribution Worldwide Distribution including USA states of CA, FL, IN, KS, MN, MO, NC, NH, NY, PA and TN, and country of Canada.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = BYE and Original Applicant = LIFE DESIGN SYSTEMS, INC.
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