FDA Medical Device Recalls (openFDA)
Origen Biomedical, Inc: Dual Lumen Cannula, 12Fr., sterile, disposable. Manufactured by OriGen Biomedical, 4020 S. Industrial Dr. #160, Austin, Texas USA 78744
- Recall number
- Z-0055-06
- Recalling firm
- Origen Biomedical, Inc
- Product
- Dual Lumen Cannula, 12Fr., sterile, disposable. Manufactured by OriGen Biomedical, 4020 S. Industrial Dr. #160, Austin, Texas USA 78744
- Status
- Terminated
- Initiated
- 2002-12-16
- Posted
- 2005-10-15
- Terminated
- 2005-11-03
- Reason
- Leak between two lumens causes reduced performance.
- Root cause
- Other
- Action
- The recall was initiated by letter to all consignees on 12/16/2002.
- Quantity
- 170 catheters
- Distribution
- The product was distributed to healthcare facilities and institutions in NC, OH, TX, CA, MO, MI, MN, LA, PA, WA, GA, RI, MD, TN, MA, KY, OR, FL, and WI. The product was distributed to the following foreign countries: United Kingdom, Canada, and Germany.
- Lot, serial or model codes
- Model V V 12F; Lot Number 36BC20121
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DQO
- Firm FEI
- 1000160256
- Firm city
- Austin
- 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