Smiths Medical ASD, Inc. Smiths Medical Oxy-PEEP High Flow O2 with PEEP; Positive end expiratory pressure breathing attachment; Reference Number: P63000; Smiths Medical, Rockland, MA 02370. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Smiths Medical Oxy-PEEP High Flow O2 with PEEP; Positive end expiratory pressure breathing attachment; Reference Number: P63000; Smiths Medical, Rockland, MA 02370.
Brand
Smiths Medical ASD, Inc.
Lot Codes / Batch Numbers
Lot Numbers: 38A30D064 and 38B09D021
Products Sold
Lot Numbers: 38A30D064 and 38B09D021
Smiths Medical ASD, Inc. is recalling Smiths Medical Oxy-PEEP High Flow O2 with PEEP; Positive end expiratory pressure breathing attachmen due to Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due to incorrectly molded part. Patient will no. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, FL, IN, KS, MN, MO, NH, NY, NC, PA, TN
Page updated: Jan 10, 2026