Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopass
FDA device recall Z-0815-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Medtronic Perfusion Systems
- Reason for recall
- An incorrect date of manufacture and incorrect use-by date were printed on the labels of the pouches used for the product.
- Action taken
- A notification letter, sent on March 25, 2004, requested that consignees complete and return an enclosed certificate which gives the consignee the option of keeping the product or returning it to the firm.
- Root cause
- Other
- Status
- Terminated
- Product code
- DTZ
- Quantity affected
- 132 units
- Distribution
- The product was shipped to consignees in Florida, Iowa, Louisiana, Maine, Minnesota and New York in the United States.
- Date initiated
- 2004-03-25
- Date posted
- 2004-07-20
- Date terminated
- 2005-11-23
- Location
- Brooklyn Park, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE (K973760) | Avecor Cardiovascular, Inc. | 1998-02-18 |
| AFFINITY CVR (K936003) | Avecor Cardiovascular, Inc. | 1994-06-20 |