Z-1086-03

Prosorba Protein A Immunoadsorption Column

Name: Z-1086-03 Prosorba Protein A Immunoadsorption Column
Creator: Fresenius Hemocare, Inc.
Published: 2003-07-11
License: https://open.fda.gov/license/

Fresenius Hemocare GmbH / initiated 2003-07-11 / Terminated / root cause: labeling and UDI

FDA source

Fresenius Hemocare, Inc. began a recall of Prosorba Protein A Immunoadsorption Column on 2003-07-11. The reason FDA records is "No package insert". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1086-03
Status: Terminated
Initiated: 2003-07-11
Posted: 2003-08-06
Terminated: 2004-01-28
Recalling firm: Fresenius Hemocare GmbH
Product: Prosorba Protein A Immunoadsorption Column
Product code: LQQ Columns, Immunoadsorption In Extracorporeal Systems
Reason for recall: No package insert
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: Lot #PNC001A

Product code LQQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)