FDA Medical Device Recalls (openFDA)
Medtronic Perfusion Systems: Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R
- Recall number
- Z-0815-04
- Recalling firm
- Medtronic Perfusion Systems
- Product
- Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R
- Status
- Terminated
- Initiated
- 2004-03-25
- Posted
- 2004-07-20
- Terminated
- 2005-11-23
- Reason
- An incorrect date of manufacture and incorrect use-by date were printed on the labels of the pouches used for the product.
- Root cause
- Other
- Action
- 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.
- Quantity
- 132 units
- Distribution
- The product was shipped to consignees in Florida, Iowa, Louisiana, Maine, Minnesota and New York in the United States.
- Lot, serial or model codes
- Lot 0402000017
- 510(k) numbers
- ["K936003","K973760"]
- PMA numbers
- not on file
- Product code
- DTZ
- Firm FEI
- 1000116158
- Firm city
- Brooklyn Park
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28