Recall Z-1379-2008

Smiths Medical ASD, Inc. · initiated March 4, 2008

Terminated

Product

Smiths Medical FLO2 Emergency Non-rebreather High Flow O2 System; Positive end expiratory pressure breathing attachment; Reference Number: P60000; Smiths Medical, Rockland, MA 02370.

Codes / lots: Lot Numbers: 37L04D188 and 38A030257

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: Nonconforming Material/Component

Action taken

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.

Details

Recall number
Z-1379-2008
Initiated
March 4, 2008
Posted by FDA
July 16, 2008
Terminated
August 20, 2012
Product code
BYE – Attachment, Breathing, Positive End Expiratory Pressure
Quantity
650
Distribution
Worldwide Distribution including USA states of CA, FL, IN, KS, MN, MO, NC, NH, NY, PA and TN, and country of Canada.
Recalling firm
Smiths Medical ASD, Inc., Rockland, MA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-1380-2008 Smiths Medical Oxy-PEEP High Flow O2 with PEEP; Positive end expiratory pressure…Incorrect Oxygen Level: Device may not provide expected oxygen concentration or the expected flow rate due… 03/04/2008Terminated