Medtronic Trillium Affinity NT Integrated-CVR Membrance… recallZ-0815-04 · Medtronic Perfusion Systems · initiated Mar 25, 2004
Terminated All recalls posted in July 2004
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Perfusion Systems or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
An incorrect date of manufacture and incorrect use-by date were printed on the labels of the pouches used for the product.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0815-04
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Mar 25, 2004
- Posted by the FDA
- Jul 20, 2004
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 132 units
- Product code
- DTZ
- FDA submissions
- K936003, K973760
- Distribution
- The product was shipped to consignees in Florida, Iowa, Louisiana, Maine, Minnesota and New York in the United States.
Product description
Medtronic Trillium Affinity NT Integrated-CVR Membrance Oxygenator and Cardiotomy Venous Reservoir with Trillium Biopassive Surface (on the oxygenator), Model 541T-R
Code information (models, lots, serial numbers)
Lot 0402000017
Other devices under the same FDA submission
1 device cleared under K936003, K973760 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- TRILLIUM® AFFINITY NT® 95217Medtronic, Inc. · OXYGENATOR, CARDIOPULMONARY BYPASS2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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