FDA Medical Device Recalls (openFDA)
Lumend Inc: LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with ethylene oxide gas.
- Recall number
- Z-0995-04
- Recalling firm
- Lumend Inc
- Product
- LuMend brand percutaneous catheter .35'' R in plastic sealed bag, sterilized with ethylene oxide gas.
- Status
- Terminated
- Initiated
- 2004-05-18
- Posted
- 2004-07-20
- Terminated
- 2004-07-26
- Reason
- Recall initiated after Lumend received a report of a malfunction of an Outback Catheter in Ohio.
- Root cause
- Other
- Action
- Area Sales managers were contacted via phone conference on 05/18/04 and instructed to quarantine all outback catheters in their possession and notify all customers with any outback inventory to quarantine the product and make arrangements to retrieve the product from them.
- Quantity
- Quantity distributed = 122 catheters.
- Distribution
- Sent mainly to Area sales representatives.
- Lot, serial or model codes
- Model number OTB 1235, Dates of manufacture 11-2003, 03-2004 and 04-2004. Model number OTB 1245, Dates of manufacture 11-2003. 510(k) K032298.
- 510(k) numbers
- ["K032298"]
- PMA numbers
- not on file
- Product code
- DQY
- Firm FEI
- 3002912012
- Firm city
- Redwood City
- Firm state
- CA
- 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