Medtronic DLP Femoral Arterial Cannula recall
Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized…
Why was Medtronic DLP Femoral Arterial Cannula recalled?
Medtronic is recalling select lots of DLP Femoral Arterial Cannula product due to recent reports in which the user had difficulty or was unable to connect the cannula to the perfusion circuit tubing.
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?
Model 57414 / Lot Numbers: 2014124994, 2015016150, 2015016729, 2015020381, 2015021484, and 201501C886. Model 57417 / Lot Numbers: 2014125438, 2015016317, 2015016695, 2015020566, 2015021401, 2015030166, 2015030435, 2015030629, and 201503C101. Model 57421 / Lot Numbers: 2015016410 and 2015017102. Model 96017 / Lot Numbers: 2015021260 and 2015030499 Model 96021 / Lot Number: 2015021134.
- Product
- Medtronic DLP Femoral Arterial Cannula, models 57414, 57417, and 57421, and DLP Femoral Cannula Replacement Kit, Models 96017 and 96021. Sterilized…
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 1304 devices
- Distribution
- Worldwide Distribution - US Distribution including the states of : AK, AZ, CA, CO, IN, KS, LA, MN, MT, NM, NY, OH, OR, PA, TX, UT, and WI., and to the countries of : Belgium, Brazil, Canada, Colombia, Denmark, France, Germany, Greece, Hungary, India, Ireland, Italy, Korea, Morocco, Netherlands, Poland, Qatar, Russian Federation, Saudi Arabia, Slovakia, Spain, Switzerland, Turkey, and United Kingdom.
- Recall date
- July 8, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)