Prosorba Protein A Immunoadsorption Column
FDA device recall Z-1086-03 · posted 2003-08-06 · Terminated
Recall details
- Recalling firm
- Fresenius Hemocare, Inc.
- Reason for recall
- No package insert
- Action taken
- A letter dated July 10, 2003 was sent to each customer. Enclosed with the letter was the prescribing information, patient guide and column holder.
- Root cause
- Other
- Status
- Terminated
- Product code
- LQQ
- Quantity affected
- 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.
- Date initiated
- 2003-07-11
- Date posted
- 2003-08-06
- Date terminated
- 2004-01-28
- Location
- Redmond, WA
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