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Terminated

Polystan Coronary Cannula Balloon Tip. (Cardiopulmonary bypass vascular catheter).

FDA Recall Z-1061-05 · Posted 2005-08-03

Recalling FirmMaquet Inc
Recall StatusTerminated
Product CodeDWF
Date Initiated2005-05-20
Date Terminated2006-10-03
Product Quantity890 units

Reason for Recall

Upon acquisition of Jostra AG, manufacturer of Polystan Coronary Cannula Balloon Tip Catheters, Maquet was unable to confirm the catheter's FDA approval status.

Firm Action

Maquet Cardiopulmonary AG, Germany through their US firm Maquet, Inc. notified Surgemedical, Inc to return all cannula identified with the Ref. Number 22xxxx back to Maquet Cardiopulmonary.

Root Cause

Other

Distribution Pattern

Nationwide. Maquet Cardiopulmonary AG, Hirrlingen, Germany has one US distributor, Surgemedical Inc., Holland, Michigan. The firm is to return all cannula in their possession back to Maquet.

Official Source

View FDA Recall →

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

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