Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Mini/T/PU/6/1.1/1.9/63 Catalog Number : 45-213
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-1472-05
- 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: 929652 958506 959672 960718 970274 979014 979328 986234 1001729 1028094 1030285
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.