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Terminated

Vision Hollow Fiber Oxygenator with GBS Coating

FDA Recall Z-0730-04 · Posted 2004-07-20

Recalling FirmGish Biomedical Inc
Recall StatusTerminated
Product CodeDTZ
Date Initiated2004-03-04
Date Terminated2005-01-04
Product Quantity950

Reason for Recall

Customers reported leakage.

Firm Action

Firm issued recall letters to all customers on March 4, 2004 listing lot numbers and quantities shipped to them. Returns were requested.

Root Cause

Other

Distribution Pattern

NY, PA, AR, IN, IL, NH, SC, NJ, MS, MI, WI, CT, CA

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K023381VISION HOLLOW FIBER OXYGENATOR WITH GUARDIAN COATINGGish Biomedical, Inc. · 2003-03-31

Official Source

View FDA Recall →

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

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