FDA Medical Device Recalls (openFDA)
Jostra-Bentley Corporation: Spiral Gold Hollow Fiber Oxygenator with Duraflow Treatment, a hollow fiber membrane oxygenator.
- Recall number
- Z-0312-03
- Recalling firm
- Jostra-Bentley Corporation
- Product
- Spiral Gold Hollow Fiber Oxygenator with Duraflow Treatment, a hollow fiber membrane oxygenator.
- Status
- Completed
- Initiated
- 2002-11-01
- Posted
- not on file
- Terminated
- not on file
- Reason
- Separation between lid and housing unit.
- Root cause
- not on file
- Action
- Accounts notified by phone 10/9/02 and letter 11/1/02. Recalling firm is requesting return of the recalled product.
- Quantity
- 356 units
- Distribution
- OH, KY, AL, TN, FL, NY, IL, no government or military accounts
- Lot, serial or model codes
- Part Number C6918A4E (lots 63355 and 64015) Part Number C6918A3E (lots 63408, 63987, and 63988) Part Number C9315A2B (lot 63998) Part Number 60163301 (lot 64408, serial numbers starting with 7xxxxx)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- not on file
- Firm city
- The
- Firm state
- Woodlands
- 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