Baylis Medical TorFlex Transseptal Guiding Sheath Kit: Class I Recall
MedSun: Newsletter #89, November 2013

FDA MedWatch Safety Alert

FDA notified healthcare professionals of the Class 1 recall of TorFlex Transseptal Guiding Sheath Kit. The sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially migrate into a patient’s bloodstream. Customers were instructed to examine their inventory and quarantine affected lots.

Additional Information:

Baylis Medical TorFlex Transseptal Guiding Sheath Kit: Class I Recall. FDA MedWatch Safety Alert. November 6, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm373958.htm


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