Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Reported: March 19, 2014 Initiated: March 3, 2014 #Z-1164-2014
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.
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 7
- Distribution
- TX and Russia
- Location
- Maple Grove, MN
Frequently Asked Questions
What product was recalled? ▼
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.. Recalled by Boston Scientific Corporation. Units affected: 7.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 19, 2014. Severity: Moderate. Recall number: Z-1164-2014.
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