Z-0291-05

Viasys, REF BLD-8100, Pulmanex Carhill Valve Kit: Large Adult, manufactured by Unomedical, Inc of McAllen...

Name: Z-0291-05 Viasys, REF BLD-8100, Pulmanex Carhill Valve Kit: Large Adult, manufactured by Unomedical, Inc of McAllen...
Creator: Unomedical, Inc
Published: 2004-12-02
License: https://open.fda.gov/license/

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

FDA source

Unomedical, Inc began a recall of Viasys, REF BLD-8100, Pulmanex Carhill Valve Kit: Large Adult, manufactured by Unomedical, Inc of McAllen, Texas and assembled in Mexico on 2004-12-02. The reason FDA records is "Adapters have been found to be blocked or occluded - potentially preventing exhalation or inhalation". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0291-05
Status: Terminated
Initiated: 2004-12-02
Posted: 2004-12-08
Terminated: 2006-09-07
Recalling firm: Unomedical A/S
Product: Viasys, REF BLD-8100, Pulmanex Carhill Valve Kit: Large Adult, 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: 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
Product codes and lots: Lot number 29404003

Product code BZA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)