Thomas Medical Products has announced a class I recall for its Transseptal Sheath Introducer Kit, citing concerns about increased risk for device breakage.
The recall was initiated on Feb. 1, 2010 and applies to all devices manufactured and distributed from Oct. 1, 2006 to Dec. 27, 2009. The products included in the recall can also be identified under the trade names HeartSpan, CHANNEL FX, Torflex and Braided Guiding Introducer Kit.
Source here.
