Sarns brand Retrograde Cardioplegia Cannula, 13 Fr, malleable stylet, ribbed balloon, manual-inflate. Catalog # 5579
FDA device recall Z-1193-03 · posted 2003-08-29 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- Product is labeled as sterile, but inadequate package seal results in lack of assurance of sterility.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- 74DWF
- Distribution
- United States, Canada, Chile, China, Germany and Japan.
- Date initiated
- 2003-08-08
- Date posted
- 2003-08-29
- Date terminated
- 2004-03-11
- Location
- Ann Arbor, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SARNS RETROGRADE CANNULA (K925442) | 3M Health Care, Sarns | 1993-05-21 |