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Terminated

Smiths Pneupac babyPAC portable ventilator, model 100. Designed for use by qualified medical caregivers, paramedics and other trained personnel, for hospital, emergency and transport ventilation of patients during respiratory distress or insufficiency.

FDA Recall Z-0436-06 · Posted 2006-01-24

Recalling FirmSmiths Medical PM, Inc.
Recall StatusTerminated
Product CodeBTL
Date Initiated2005-12-05
Date Terminated2006-12-26
Product Quantity44

Reason for Recall

A potential safety related problem associated with the Pnuepac babyPac Ventilator model 100 has been discovered in that the interface between the air input hose and the air input fitting may leak, and if tightened too much, the air input fitting may loosen when trying to remove the air hose.

Firm Action

Consignees were provided a Safety Action Bulletin, number 05-SAB05, dated 12/05/05. This requests that affected devices be quarantined, Smiths Medical be contacted and devices ultimately be returned to Smiths Medical Pm, Inc. Service Departmentfor repair.

Root Cause

Other

Distribution Pattern

CA, CO, IN,MN, NY, PA, TN, TX

Official Source

View FDA Recall →

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

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