TAXUS Express Paclitaxel-Eluting MONORAIL Coronary Stent System (3.5 x 32mm). || On August 5, 2004 an additional 38 lots were added to this recall, the following TAXUS Express2 Paclitaxel-Eluting Coronary Stent System Part Numbers correspond to the lot numbers listed at the end of the code information below. US part# H7493897024250 H7493897032270 H7493897020300 H7493897020350 H7493897032300 H7493897020350 H7493897024300 H7493897020300 H7493897020300 H7493897032350 H7493897020250 H7493897020270 H7493897024300 H7493897032350 H7493897032270 H7493897020350 H7493897024300 H7493897024250 H7493897024250 H7493897020300 H7493897032350 H7493897032350 H7493897024350 H7493897024250 H7493897024250 H7493897016300 H7493897032350 H7493897024350 H7493897016350 H7493897032300 H7493897016350 H7493897016350 H7493897024350 H7493897016250 H7493897016250 H7493897024300 H7493897024350 H7493897016250 OUS part# H7493800132270 H7493800132270 H7493800132350 H7493800132270 H7493800124350
No 2.25 mm lots were distributed in U.S. U.S Distributed - 2.5 mm - Lot number/Exp. Date: 6171851 May-04 U.S Distributed - 2.75 mm - Lot number/Exp. Date: 6294706 Jun-04 U.S Distributed - 3.0 mm - Lot number/Exp. Date: 6337153 Jul-04 6422009 Aug-04 6555155 Sep-04 6271481 Jun-04 U.S Distributed - 3.5mm - Lot number/Exp. Date: 6111269 Apr-04 No 4.0 mm lots distributed in U.S. No TAXUS OTW were sold outside the U.S.
Within the US to GA, MS, NC ,TN. OUS to include: Canada, Hong Kong, Italy, Netherlands, Saudi Arabia, United Kingdom
Description du dispositif
Mach 1 6F Kimny Guide Catheter. Catalog No. 34356-583. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacturer: Boston Scientific Scimed, Inc., One Scimed Place, Maple Grove, MN USA 55311.