FDA Medical Device Recalls (openFDA)
Unomedical, Inc: 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
- Recall number
- Z-0289-05
- Recalling firm
- Unomedical, Inc
- Product
- 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
- Status
- Terminated
- Initiated
- 2004-12-02
- Posted
- 2004-12-08
- Terminated
- 2006-09-07
- 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
- 34 cases; 50 units/case (1,700 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
- Lot, serial or model codes
- Lot numbers 27904001 and 29504001
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BZA
- Firm FEI
- 1000160240
- Firm city
- Mcallen
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28