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Terminated

Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit.

FDA Recall Z-1716-2008 · Posted 2008-08-26

Recalling FirmCaire, Inc.
Recall StatusTerminated
Product CodeBYJ
Date Initiated2007-10-23
Date Terminated2009-12-17
Product Quantity3470

Reason for Recall

Moisture ingress into the electronic liquid level indicator may cause inaccurate liquid oxygen level readings. The oxygen could run out without the patient knowledge.

Firm Action

A Technical Service Bulletin was sent to consignees on/about October 23, 2007 to notify customers of the potential issue. Technical support and information for ordering replacement Generation 4 liquid gauges were offered. For technical concerns or if you have not received the notification from the firm, contact U.S. Technical Service at 1-800-482-2473 or European Technical Service at +44 (0) 797 1260077.

Root Cause

Device Design

Distribution Pattern

U.S. Nationwide and the following foreign countries: Argentina, Austria, Brazil, Canada, China, Chile, Central America/Caribbean, Colombia, Costa Rica, Europe, Austria, Belgium, Denmark, France, Germany, Greece, Hungary, Irish Republic, Italy, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, United Kingdom, Mexico, South America, Peru and Uruguay.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K050153SPIRIT, MODEL HASCaire, Inc. · 2005-04-15

Official Source

View FDA Recall →

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

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