Medtronic Perfusion Tubing Packs recall
Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and components are…
Why was Medtronic Perfusion Tubing Packs recalled?
This recall is being initiated due to a potential breach of the Tubing Pack Header Bags manufactured in these select lots. The seal in question is between the Tyvek and the Poly side of the header bag.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Lot Numbers Lot Number HY2W85R9 209704344,209704345,209704346, 209704347,210010558 TL7M64R3 209789393 TL7P17R1 209789333
- Product
- Medtronic Perfusion Tubing Packs, Models TL7M64R3, TL7P17R1 & HY2W85R9, Sterilized using Ethylene Oxide. The Tubing Pack design and components are…
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 496
- Distribution
- Nationwide Distribution including US: AL, IL, IN, and WI.
- Recall date
- November 18, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)