FDA Medical Device Recalls (openFDA)
Gish Biomedical Inc: Vision Hollow Fiber Oxygenator
- Recall number
- Z-0780-03
- Recalling firm
- Gish Biomedical Inc
- Product
- Vision Hollow Fiber Oxygenator
- Status
- Terminated
- Initiated
- 2003-03-31
- Posted
- 2003-04-22
- Terminated
- 2004-03-09
- Reason
- Two reports of leakage.
- Root cause
- Other
- Action
- The firm sent recall letters by fax on March 31, 2003 requesting that the customer make arrangements to return the product.
- Quantity
- 1749
- Distribution
- Nationwide, Austria, Canada, Japan, Saudi Arabia
- Lot, serial or model codes
- Lot 205200
- 510(k) numbers
- ["K961530"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 2021836
- Firm city
- Rancho Santa Margarita
- 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