Recalls / —

—#40606

Product

Vaxcel Plus Chronic Dialysis Catheters - Catheter/CPU/15/19/Plastic Catalog Number : 45-541

FDA product code

KOB — Catheter, Suprapubic (And Accessories)

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K032712

Affected lot / code info

Lot Numbers: 973523 974713 993812 993813 1000935 1000936 1000937 1000938 1000939 1002367 1009153 1018969 1018970 1018971 1027107 1027108 1027109 1027110 1027111 1028098

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 #40606. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.