Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Mini/T/PU/6/1.1/1.9/63 Catalog Number : 45-213
FDA device recall Z-1472-05 · posted 2005-09-02 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KOB
- Distribution
- Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula
- Date initiated
- 2005-07-22
- Date posted
- 2005-09-02
- Date terminated
- 2007-06-20
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VAXCEL WITH PASV PORT, MODEL 45-213 (K032008) | Boston Scientific Corp | 2003-07-14 |