| Subject: | Class I Recall of Torflex Transseptal Guiding Sheath |
| Category: | Food and Drug Administration (FDA)
|
| Published: | Fri, 12 Mar 2010 - 12:00 pm |
| The Food and Drug Administration (FDA) has notified healthcare professionals of the Class I recall of Torflex Transseptal Guiding Sheath, a medical device used to pass heart catheters from the right to the left side of the heart. The product is being recalled because the sheath tip may break off and separate during heart procedures. If this occurs, the fragment could move through the heart and arteries to vital organs, causing a blockage anywhere, including the brain or heart. This could lead... The full article is available to StayAlert subscribers. Click here for a free trial subscription. |
|
RESOURCES:
External Links:
|
|
StayAlert! notifies healthcare customers of all federal and regulatory body legislation changes impacting the healthcare industry, including TJC (JCAHO), CDC, CMS, DHHS, FDA, OSHA, OIG and many others. StayAlert! complements this with regulatory implementation action plans. StayAlert! serves as a virtual healthcare department, augmenting traditional employee staffed departments and freeing employees to perform other vital functions. The strength of StayAlert! rests in its ability to allow healthcare organizations to streamline their businesses using the Internet as a foundation architecture. StayAlert! provides cost containment and reduction through elimination of unnecessary overhead, and work caused by errors or poor access to information. |
|
