Medtronic Perfusion Tubing Packs Recalled for Potential Header Bag Seal Breach
Medtronic is recalling 496 Perfusion Tubing Packs due to a potential breach in the header bag seal. The affected lots were distributed nationwide in the US.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a potential breach of the sterile barrier, which is a theoretical risk of contamination without reported illnesses or injuries in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Medtronic Perfusion Systems is recalling 496 units of Perfusion Tubing Packs, specifically Models TL7M64R3, TL7P17R1, and HY2W85R9. These sterile packs are intended for use in the extracorporeal circuit during cardiopulmonary bypass procedures. The recall is being initiated due to a potential breach in the Tubing Pack Header Bags manufactured in specific lots. The seal in question is located between the Tyvek and the Poly side of the header bag.
The affected lots include HY2W85R9 (Lot Numbers 209704344, 209704345, 209704346, 209704347, 210010558), TL7M64R3 (Lot Number 209789393), and TL7P17R1 (Lot Number 209789333). The products were distributed nationwide, including in the states of Alabama, Illinois, Indiana, and Wisconsin.
Healthcare facilities and users should check their inventory for these specific model and lot numbers. If the affected products are found, they should be removed from use and returned to Medtronic Perfusion Systems or the distributor in accordance with the recall instructions.
The recalled product
- Product
- Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and components are specified by the user, they are packaged with consideration of setup efficiency and respect for the environment, and they are…
- Manufacturer
- Medtronic Perfusion Systems
- Affected units
- 496
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model Lot Numbers Lot Number HY2W85R9 209704344
- 209704345
- 209704346
- 209704347
Distribution
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