DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standard luer sites to facilitate direct connections to the cannulae
Reported: August 2, 2017 Initiated: June 22, 2017 #Z-2765-2017
Product Description
DLP Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standard luer sites to facilitate direct connections to the cannulae
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 Antegrade/Retrograde Adapter Method for perfusion of cardioplegia alternately in either an antegrade or retrograde fashion. It is fitted with flexible lines and standard luer sites to facilitate direct connections to the cannulae. 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-2765-2017.
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