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Terminated

Sarns brand Retrograde Cardioplegia Cannula, 17 Fr, malleable stylet, ribbed balloon, manual-inflate. Catalog # 4430

FDA Recall Z-1191-03 · Posted 2003-08-29

Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product Code74DWF
Date Initiated2003-08-08
Date Terminated2004-03-11

Reason for Recall

Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility.

Firm Action

Urgent device recall letters were sent to customers on August 8, 2003. Distributors were advised to notify their customers of this recall. Product is to be returned to Terumo.

Root Cause

Other

Distribution Pattern

United States, Canada, Chile, China, Germany and Japan.

Official Source

View FDA Recall →

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

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