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Terminated

Prosorba Protein A Immunoadsorption Column

FDA Recall Z-1086-03 · Posted 2003-08-06

Recalling FirmFresenius Hemocare, Inc.
Recall StatusTerminated
Product CodeLQQ
Date Initiated2003-07-11
Date Terminated2004-01-28
Product Quantity19 cases/6 columns each

Reason for Recall

No package insert

Firm 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.

Root Cause

Other

Distribution Pattern

The firm distributed to 10 hospitals and health care facilities in AZ, CA, MI, MN, MO, PA, TN, TX, VA.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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