FloTrac Sensor recall
FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring.
Why was FloTrac Sensor recalled?
Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
MHD8: UDI: 00690103194609/ Lot # 64874824, 64886991, 64897466, 64982736; MHD85: UDI: 00690103194616/ Lot # 64858315; MHD6R5: UDI:07460691949737/Lot # 65008717, 65008718; MHD8R: UDI: 07460691949829/Lot # 64892236, 65009105; MHD8R5: UDI:07460691949744/Lot # 64886927; MHD8S: UDI: 07460691949805/Lot # 65048926
- Product
- FloTrac Sensor, REF: MHD8 & MHD85,MHD6R5, MHD8R, MHD8R5, MHD8S, STERILEEO, Rx only. For use in intravascular pressure monitoring.
- Recalling firm
- Edwards Lifesciences, LLC
- Quantity
- 1417 units
- Distribution
- US: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA WA WI WV WY OUS: Argentina Australia Austria Bahrain Belgium Brazil Canada CANARY ISLANDS Chile Colombia Costa Rica Czech Republic Denmark Ecuador Faroe Islands France Germany Greece Guatemala Hong Kong Indonesia Ireland Israel Italy Japan Malaysia Netherlands New Zealand Northern Ireland Norway Panama Poland Portugal Saudi Arabia Singapore Slovakia Slovenia South Korea Spain Sweden Switzerland United Arab Emirates (UAE) United Kingdom Vietnam
- Recall date
- December 6, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)