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
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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
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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 |
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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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510(K) Database | 510(K)s with Product Code = BYE
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