Recalls / —

—#40584

Product

Banana Peel™ Sheaths BP/14/30 Catalog Number : 20-615

FDA product code

KOB — Catheter, Suprapubic (And Accessories)

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K961219

Affected lot / code info

Lot Numbers:  6793485 6823850 6844355 6930078 6956437 7021217 7069903 7091052 7157491 7330327 7382532 7397499 7532023 7560739 7571551 7596740 7684618 7700506

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 #40584. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.