Recall Z-1086-03 ยท LQQ Columns, Immunoadsorption In Extracorporeal Systems
Fresenius Hemocare, Inc.
Prosorba Protein A Immunoadsorption Column
| Date | Aug 6, 2003 (initiated Jul 11, 2003) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.