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U.S. Department of Health and Human Services

Class 2 Device Recall Smiths Medical FLO2 Emergency Nonrebreather High Flow O2 System

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 Class 2 Device Recall Smiths Medical FLO2 Emergency Nonrebreather High Flow O2 Systemsee related information
Date Initiated by FirmMarch 04, 2008
Date PostedJuly 16, 2008
Recall Status1 Terminated 3 on August 20, 2012
Recall NumberZ-1379-2008
Recall Event ID 46947
Product Classification Positive End Expiratory Pressure Attachment Breathing - Product Code BYE
ProductSmiths Medical FLO2 Emergency Non-rebreather High Flow O2 System; Positive end expiratory pressure breathing attachment; Reference Number: P60000; Smiths Medical, Rockland, MA 02370.
Code Information Lot Numbers: 37L04D188 and 38A030257
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
ActionConsignees 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 Commerce650
DistributionWorldwide Distribution including USA states of CA, FL, IN, KS, MN, MO, NC, NH, NY, PA and TN, and country of 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.
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