Recall Z-1164-2014— Boston Scientific Corporation

Name: FDA recall Z-1164-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-03

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2014-03-03, terminated 2014-06-09. It names one FDA 510(k) clearance: K033441. Product: Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.. Reason: The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2014-03-03
Terminated: 2014-06-09
Firm location: Maple Grove, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K033441 — BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETERBoston Scientific Corp·cleared 2003-11-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.

Reason for recall

The sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy.

Data sourced from openFDA. This site is unofficial and independent of the FDA.