FDA Recall
Terminated
Sarns brand Retrograde Cardioplegia Cannula, 17 Fr, steerable stylet, ribbed balloon, manual-inflate. Catalog # 4428
Recall: Z-1190-03
·
Initiated August 8, 2003
Recall
- Recall Number
- Z-1190-03
- Event Number
- 27041
- Firm
- Terumo Cardiovascular Systems Corp
- FEI Number
- 1828100
- Product Code
- 74DWF
- Status
- Terminated
- Root Cause
- Other
- Initiated
- August 8, 2003
- Posted
- August 29, 2003
- Terminated
- March 11, 2004
- Address
- 6200 Jackson Rd., Ann Arbor, MI, 48103
Description
Sarns brand Retrograde Cardioplegia Cannula, 17 Fr, steerable stylet, ribbed balloon, manual-inflate. Catalog # 4428
Reason
Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility.
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.
Distribution
United States, Canada, Chile, China, Germany and Japan.