Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Standard/PS/PU/8/1.6/2.6/63 Catalog Number : 45-356
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-1484-05
- 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: 916200 921356 945848 958513 962137 970277 979019 979836 987578 1001739 1002354 1003620 1006322 962137D
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.