Terumo Cardiovascular Systems Corp Sarns brand Retrograde Cardioplegia Cannula, 17 Fr, steerable stylet, ribbed balloon, manual-inflate. Catalog # 4428 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Sarns brand Retrograde Cardioplegia Cannula, 17 Fr, steerable stylet, ribbed balloon, manual-inflate. Catalog # 4428
Brand
Terumo Cardiovascular Systems Corp
Lot Codes / Batch Numbers
Lots 1200590 and 1200600.
Products Sold
Lots 1200590 and 1200600.
Terumo Cardiovascular Systems Corp is recalling Sarns brand Retrograde Cardioplegia Cannula, 17 Fr, steerable stylet, ribbed balloon, manual-inflate due to Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility.
Recommended Action
Per FDA guidance
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.
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