Viasys, REF BLD-1000, Pulmanex Adapter 22mm O.D. x 22mm O.D. x 15 mm I.D., manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico
FDA Recall Z-0289-05 · Posted 2004-12-08
Recalling FirmUnomedical, Inc
Recall StatusTerminated
Product CodeBZA
Date Initiated2004-12-02
Date Terminated2006-09-07
Product Quantity34 cases; 50 units/case (1,700 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.