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Terminated

SafeSheath CSG (Coronary Sinus Guide) KR-90.09 and CSG (Coronary Sinus Guide) KR/BCor-90.09. These sheaths are packaged in 5 individual boxed kits per case carton.

FDA Recall Z-1086-04 · Posted 2004-07-20

Recalling FirmThomas Medical Products Inc
Recall StatusTerminated
Product CodeDYB
Date Initiated2004-06-11
Date Terminated2005-06-27
Product Quantity39,605 kits

Reason for Recall

Degradation of sheath due to excessive exposure to (ultra violet) fluorescent light.

Firm Action

The recalling firm send a recall letter via fax and Federal Express 6/11/2004 to the various wholesalers and/or distributors informing them of the recall and to return all product to the recalling firm.

Root Cause

Other

Distribution Pattern

The recall product was distributed to various distributors in the following states: CA and PA. There are no foreign or government accounts.

Official Source

View FDA Recall →

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

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