Tunneled Central Venous Catheters With PASV Valve Technology And Polyester Cuff - PASV CVC/TL/10/IK Catalog Number: CVC1
FDA device recall Z-1508-05 · 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 |
|---|---|---|
| CLAMPLESS VALVED CATHETER - TUNNELED (CVC-T) (K963806) | Bmw Medical, Inc. | 1996-12-12 |