FDA-Device2014-03-19Class II
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Boston Scientific Corporation
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.
Sold states
TX and Russia
Affected count
7
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1164-2014Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief