Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannulae, manual -inflate, 17 Fr, guidewire stylet, ribbed balloon; catalog number 4427. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sarns brand Retrograde Cardioplegia Cannulae, manual -inflate, 17 Fr, guidewire stylet, ribbed balloon; catalog number 4427.
Brand
Terumo Cardiovascular Systems Corp
Lot Codes / Batch Numbers
All lots.
Products Sold
All lots.
Terumo Cardiovascular Systems Corp is recalling Sarns brand Retrograde Cardioplegia Cannulae, manual -inflate, 17 Fr, guidewire stylet, ribbed ballo due to The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026