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Terminated

Viasys, REF BLD-14772, Pulmanex Adult Transport Ventilator Circuit with Exhalation Valve, Non-Heated, 72'', manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico

FDA Recall Z-0287-05 · Posted 2004-12-08

Recalling FirmUnomedical, Inc
Recall StatusTerminated
Product CodeBZA
Date Initiated2004-12-02
Date Terminated2006-09-07
Product Quantity251 cases; 20 units/case (5,020 units total)

Reason for Recall

Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation

Firm Action

The firm issued a Public Safety Alert on 11/30/2004. The firm expanded their safety alert on 12/02/2004 and issued press informing of a recall. The firm sent recall letters to consignees on 12/02/2004.

Root Cause

Other

Distribution Pattern

The product was distributed nationwide to hospitals, home healthcare, and medical transport. Distribution to foreign countries included: Canada; Russia; France; Switzerland; Argentina; Uruguay; and Mexico

Official Source

View FDA Recall →

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

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