Home / Recalls / Medical Devices
Boston Scientific Corporation recalls Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Recalled March 19, 2014 · FDA recall Z-1164-2014 · Boston Scientific
Hazard
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. · FDA Class II
Units
7
Sold at
TX and Russia
Description
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.
Product
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Manufacturer(s)
Boston Scientific Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →