Prosorba Protein A Immunoadsorption Column
- Company
- Fresenius Hemocare, Inc.
- Recall Initiated
- July 11, 2003
- Posted
- August 6, 2003
- Terminated
- January 28, 2004
- Recall Number
- Z-1086-03
- Quantity
- 19 cases/6 columns each
- Firm Location
- Redmond, WA
Reason for Recall
No package insert
Distribution
The firm distributed to 10 hospitals and health care facilities in AZ, CA, MI, MN, MO, PA, TN, TX, VA.
Lot / Code Info
Lot #PNC001A
Root Cause
Other
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.