Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 17 Fr, malleable stylet, ribbed balloon, temperature monit
FDA device recall Z-1347-04 · posted 2004-08-17 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
- Action taken
- 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
- Status
- Terminated
- Product code
- DWF
- Distribution
- United States, Brazil, Canada, Chile, Colombia, El Salvador, Germany, Hong Kong, Malaysia, Mexico, Nicaragua, South Africa, Taiwan, Thailand, United Arab Emirate, Uruguay and Wales.
- Date initiated
- 2004-07-07
- Date posted
- 2004-08-17
- Date terminated
- 2004-10-26
- Location
- Ann Arbor, MI
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