FDAFDA · Food and drugs·Recall number Z-1164-2014
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Published March 19, 2014 · Recall initiated: March 3, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Boston Scientific Corporation
- Distributor
- TX and Russia
- Lot
- 2013040058
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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