Recall Z-0291-05 ยท BZA Connector, Airway (Extension)
Unomedical, Inc
Viasys, REF BLD-8100, Pulmanex Carhill Valve Kit: Large Adult, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico
| Date | Dec 8, 2004 (initiated Dec 2, 2004) |
| Status | Terminated |
| Reason | Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation |
| 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 | 32 cases; 10 units/case (320 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.