Magellan Robotic Catheter Accessory Kits recall
Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan System is a robotic control system…
Why was Magellan Robotic Catheter Accessory Kits recalled?
Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kGy.
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?
Lot number 20151117
- Product
- Magellan Robotic Catheter Accessory Kits, Model number MACC 50 and MACC80. Cardiology: The Hansen Medical Magellan System is a robotic control system…
- Recalling firm
- Hansen Medical Inc
- Quantity
- 8 kits
- Distribution
- Nationwide Distribution to OH, TX. FL, CA and GA.
- Recall date
- May 4, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)