Vaxcel Chest Ports - Mini/T/S/8/1.5/2.6/63 Catalog Number : 45-310
This recall has been terminated (originally issued September 2, 2005).
- Company
- Boston Scientific Corporation
- Recall Initiated
- July 22, 2005
- Posted
- September 2, 2005
- Terminated
- June 20, 2007
- Recall Number
- Z-1477-05
- Firm Location
- Natick, MA
- Official Source
- View on FDA website ↗
Reason for Recall
The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
Distribution
Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula
Lot / Code Info
Lot Numbers: 897963 899779 905283 905540 905795 912253 912714 918871 919149 920316 926376 926666 934740 935754 937478 938097 938491 942049 942282 948073 953631 958509 958815 959675 968284 968734 969544 970794 972100 974707 975769 976229 978021 980595 981357 991171 991172 991173 991174 991438 992989 1000900 1000901 1000902 1001276 1002352
Root Cause
Other
Action Taken
Boston Scientific intiated the recall on 7/22/05 to direct accounts and to distributors on 7/ 27 /05. Distributors are requested to conduct sub recalls to the medical facility level. A revised letter dated 8/2/05 was sent to 18 US accounts for one lot (#1020895) omitted in the letter of 7/22/05.