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
Reported: August 2, 2017 Initiated: June 22, 2017 #Z-2766-2017
Product Description
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
Reason for Recall
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Details
- Recalling Firm
- Medtronic Perfusion Systems
- Units Affected
- 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.
- Location
- Brooklyn Park, MN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Medtronic Perfusion Systems. Units affected: 63053 (48180 US) (14873 OUS).
Why was this product recalled? ▼
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 2, 2017. Severity: Moderate. Recall number: Z-2766-2017.
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