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Terminated

Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 15 Fr, guidewire stylet, smooth balloon; catalog number 7270.

FDA Recall Z-1356-04 · Posted 2004-08-17

Recalling FirmTerumo Cardiovascular Systems Corp
Recall StatusTerminated
Product CodeDWF
Date Initiated2004-07-07
Date Terminated2004-10-26

Reason for Recall

The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.

Firm Action

The firm issued a recall letter for some lots on 7/7/04, instructing customers to examine stocks on hand for open packages and to return product without a package seal. The recall was extended to all lots via a second recall letter dated July 29, 2004.

Root Cause

Other

Distribution Pattern

United States, Brazil, Canada, Chile, Colombia, El Salvador, Germany, Hong Kong, Malaysia, Mexico, Nicaragua, South Africa, Taiwan, Thailand, United Arab Emirate, Uruguay and Wales.

Official Source

View FDA Recall →

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

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