Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0287-05

Viasys, REF BLD-14772, Pulmanex Adult Transport Ventilator Circuit with Exhalation Valve, Non-Heated, 72''...

Unomedical A/S / initiated 2004-12-02 / Terminated

Unomedical, Inc began a recall of Viasys, REF BLD-14772, Pulmanex Adult Transport Ventilator Circuit with Exhalation Valve, Non-Heated, 72'', manufactured by Unomedical, Inc of McAllen, Texas... on . The reason FDA records is "Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0287-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Unomedical A/S
Product
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
Product code
BZA Connector, Airway (Extension)
Reason for recall
Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation
FDA root cause
Other
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.
Quantity in commerce
251 cases; 20 units/case (5,020 units total)
Distribution
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
Product codes and lots
Lot numbers 23604005 and 31504003