ClearanceBrief
Recall Z-1225-2011 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Thomas Medical Products Inc

Thomas Medical Products, Y-Glide (Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass) for use during vascular interventional procedures. Part No. FTB-021-00, Catalog No. FTB-021-00.

DateFeb 14, 2011 (initiated Dec 16, 2010)
StatusTerminated
ReasonCompromised sterility/weak or open seals.
Root causePackaging process control
ActionGE Healthcare Thomas medical products Recall notification dated 16 December 2010 (GEHC Ref # 35003) was sent by letter via UPS Next Day Air and/or USPS certified mail.
Quantity28,679 for all products
DistributionDistribution Nationwide USA and Germany.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K003731SAFESHEATH MSP INTRODUCER SHEATH KIT WITH INTEGRAL HEMOSTASIS VALVE
Thomas Medical Products, Inc., Apr 10, 2001
K072745Y-GLIDE
Thomas Medical Products, Inc., Jan 4, 2008
K934901TEAR-AWAY SHEATH INTRODUCER SET WITH INTEGRAL HEMOSTASIS VALVE
Thomas Medical Products, Inc., Jan 21, 1994