DLP Cardioplegia Adapter with Pressure Port Provides recall
DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These…
Why was DLP Cardioplegia Adapter with Pressure Port Provides recalled?
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
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 No. 15004; Product UPN 20613994900412; Lot No. 2016031072, 2016031509, 2016050243, 2016081219, 2016100630, 2016120083, 2016120448, 2017040113.
- Product
- DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These…
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 63053 (48180 US) (14873 OUS)
- Distribution
- Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Denmark, El Salvador, France, Georgia, Germany, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Macedonia, Moldova, Netherlands, New Zealand, Nigeria, Norway, Poland, Romania, Russian Federation, Slovenia, Spain, Thailand, Turkey, & United Kingdom.
- Recall date
- August 2, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)