Recalls / —
—#40602
Product
Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Standard/PS/PU/8/1.6/2.6/63 Catalog Number : 45-356
- FDA product code
- KOB — Catheter, Suprapubic (And Accessories)
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- Affected lot / code info
- Lot Numbers: 916200 921356 945848 958513 962137 970277 979019 979836 987578 1001739 1002354 1003620 1006322 962137D
Why it was recalled
The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
Root cause (FDA determination)
Other
Action the firm took
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.
Recalling firm
- Firm
- Boston Scientific Corporation
- Address
- 1 Boston Scientific Pl, Natick, Massachusetts 01760-1536
Distribution
- Distribution pattern
- Nationwide VA Hopsitals Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula
Timeline
- Recall initiated
- 2005-07-22
- Posted by FDA
- 2005-09-02
- Terminated
- 2007-06-20
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #40602. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.