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Teleflex Balloon Pump Catheters In Class I Recall

Law360 (April 14, 2009, 12:00 AM EDT) -- More than 45,000 of Teleflex Medical unit Arrow International's balloon pump catheters have been recalled after a potentially fatal pump tubing assembly flaw was discovered.

North Carolina-based Teleflex said Monday that the U.S. Food and Drug Administration had classified the medical device recall of the volume connectors for Arrow's 30cc, 40cc and 50cc intra aortic balloon pump catheters as a Class I recall.

The FDA defines Class I recalls as “a situation in which there is a reasonable probability that the use of or exposure to...
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