A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex recall
A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001…
Why was A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex recalled?
Updated instructions for use: Ultra-Flex MYO/WIRE Monopolar pacing wire looped electrode (M-21 Series) to be consistent between electrode IFU and instructions for M-21 loop.
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?
Lots 0715A or later
- Product
- A&E Medical Corp. Ultra-Flex MYO/Wire Ultra-Flex Monopolar Pacing Wire Looped Electrode (M-21 SERIES)- Temporary Pacing Electrode as follows: 021-001…
- Recalling firm
- Alto Development Corp
- Quantity
- 351.5 Boxes
- Distribution
- Distribution US Nationwide, Czech Republic, Italy, Israel, and UK.
- Recall date
- August 7, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)