Medtronic Select CAP Arterial Cannulae. Vented recall
Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.), 78822 (22 Fr.). Non-Vented Cannulae, model 78920 (20 Fr.)…
Why was Medtronic Select CAP Arterial Cannulae. Vented recalled?
Medtronic is recalling all models of its Select 3D and Select CAP Arterial Cannula product families due to reports of the cannula body splitting near the suture collar.
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 78818, Lot Numbers: 2011021826, 2011070534, 2011090245, 2011110207, 2011111844. Model 78820, Lot Numbers: 2011062305, 2011072337. Model 78822, Lot Number: 2011011178 Model 78920, Lot Numbers: 2011050717, 2011082464, 2011120308, 2012070891, 2012071268, 2013081135, 2013121551, 201106C038. Model 78922, Lot Numbers: 2011011187, 2011020121, 2011020785, 2011021532, 2011070801, 2011081266, 2011090483, 2012012160, 2012021436, 2012021695, 2012071735, 2013010416, 2013030273, 2013050807, 2013051036, 2013070174, 2013091410, 2013101028, 201311C767. Model 78924, Lot Numbers: 2011041201, 2011041542, 2011080058, 2011080606, 2011081545, 2011081637, 2011110914, 2012031176, 2012051794, 2012100256, 2012111224, 2013030583, 2013050865, 2013060210.
- Product
- Medtronic Select CAP Arterial Cannulae. Vented, models 78818 (18 Fr.), 78820 (20 Fr.), 78822 (22 Fr.). Non-Vented Cannulae, model 78920 (20 Fr.)…
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management
- Quantity
- 19483 total (7669 US, 11814 OUS)
- Distribution
- Worldwide distribution: US (Nationwide) including Puerto Rico, and Internationally to: Algeria, Argentina, Austria, Belgium, Bosnia And Herzegovina, Brazil, Canada, Cyprus, El Salvador, France, Georgia, Germany, Greece, Hungary, India, Ireland, Italy, Japan, Jordan, Kuwait, Netherlands, Oman, Paraguay, Poland, Portugal, Russian Federation, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom, Venezuela, and Yemen.
- Recall date
- February 26, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)