"***Flo Trac Sensor recall: Sterility Concern
"***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
Why was "***Flo Trac Sensor recalled?
The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance related to incorrect packaging configuration where the IFU was placed on top of the Tyvek instead of being placed at the bottom of the box. There is no evidence available at this time that could validate the sterility of this incorrect packaging configuration.
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?
595531157
- Product
- "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters.
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 35 units
- Distribution
- Nationwide Distribution including MO and MI.
- Recall date
- September 18, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)