Recalls / —

—#40592

Product

Vaxcel Chest Ports - Mini/T/S/8/1.5/2.6/63 Catalog Number : 45-310

FDA product code

KOB — Catheter, Suprapubic (And Accessories)

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K030083

Affected lot / code info

Lot Numbers: 897963 899779 905283 905540 905795 912253 912714 918871 919149 920316 926376 926666  934740 935754 937478 938097 938491 942049 942282 948073  953631 958509 958815 959675 968284 968734 969544 970794  972100 974707 975769 976229 978021 980595 981357 991171  991172 991173 991174 991438 992989 1000900 1000901 1000902 1001276 1002352

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 #40592. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.