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Terminated

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

FDA Recall Z-1379-2008 · Posted 2008-07-16

Recalling FirmSmiths Medical ASD, Inc.
Recall StatusTerminated
Product CodeBYE
Date Initiated2008-03-04
Date Terminated2012-08-20
Product Quantity650

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.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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