FDA Medical Device Recalls (openFDA)
Fresenius Hemocare, Inc.: Prosorba Protein A Immunoadsorption Column
- Recall number
- Z-1086-03
- Recalling firm
- Fresenius Hemocare, Inc.
- Product
- Prosorba Protein A Immunoadsorption Column
- Status
- Terminated
- Initiated
- 2003-07-11
- Posted
- 2003-08-06
- Terminated
- 2004-01-28
- Reason
- No package insert
- Root cause
- Other
- Action
- A letter dated July 10, 2003 was sent to each customer. Enclosed with the letter was the prescribing information, patient guide and column holder.
- Quantity
- 19 cases/6 columns each
- Distribution
- The firm distributed to 10 hospitals and health care facilities in AZ, CA, MI, MN, MO, PA, TN, TX, VA.
- Lot, serial or model codes
- Lot #PNC001A
- 510(k) numbers
- not on file
- PMA numbers
- ["P850020","P850020S011"]
- Product code
- LQQ
- Firm FEI
- 3002987955
- Firm city
- Redmond
- Firm state
- WA
- 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