FDAFDA · Food and drugs·Recall number Z-2766-2017
DLP Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These adapters are intended for use in conjunction with the delivery of cardioplegia solution and to provide access for pressure monitoring for up to six hours
Published August 2, 2017 · Recall initiated: June 22, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Perfusion Systems
- Distributor
- 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.
- Lot
- Model No. 15004; Product UPN 20613994900412; Lot No. 2016031072, 2016031509, 2016050243, 2016081219, 2016100630, 2016120083, 2016120448, 2017040113.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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