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.
Baylis Medical TorFlex Transseptal Guiding Sheath Kit: Class I Recall. FDA MedWatch Safety Alert. November 6, 2013.