—#68611

Product

Smiths Medical Oxy-PEEP High Flow O2 with PEEP; Positive end expiratory pressure breathing attachment; Reference Number: P63000; Smiths Medical, Rockland, MA 02370.

FDA product code: BYE — Attachment, Breathing, Positive End Expiratory Pressure
Device class: Class 2
Medical specialty: Anesthesiology
510(k) numbers: K854822
Affected lot / code info: Lot Numbers: 38A30D064 and 38B09D021

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 160 Weymouth St, Rockland, Massachusetts 02370-1136

Distribution

Distribution pattern: Worldwide Distribution including USA states of CA, FL, IN, KS, MN, MO, NC, NH, NY, PA and TN, and country of Canada.

Timeline

Recall initiated: 2008-03-04
Posted by FDA: 2008-07-16
Terminated: 2012-08-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #68611. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.