Z-1164-2014 Class II Terminated
FDA device recall Z-1164-2014 was initiated by Boston Scientific Corporation on Mar 3, 2014 and is designated Class II. 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… The recall status is terminated (terminated Jun 9, 2014). Affected quantity: 7.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 19, 2014
- Initiation Date
- Mar 3, 2014
- Termination Date
- Jun 9, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7
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.
Distribution Pattern
TX and Russia
Code Information
2013040058
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1164-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026