Cardio Medical Products recall
Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured…
Why was Cardio Medical Products recalled?
Covidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101.
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?
510 K K103159 Part number O101 Lot numbers Y111412-2 Y111912-17 Y020613-03
- Product
- Cardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured…
- Recalling firm
- Cardio Medical Products
- Quantity
- 657 units
- Distribution
- Nationwide Distribution
- Recall date
- July 17, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)