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Recall Observatory FDA recall evidence

Device product

Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.

Z-1164-2014

March 03, 2014

Class II

Product summary

Firm
Boston Scientific Corporation
Event
Event 67658
Status
Terminated
Classification
Class II
Quantity
7
Official record key
device-enforcement:Z-1164-2014

Official wording

Reason: 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.

Code information: 2013040058

Distribution pattern: TX and Russia

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    pouch of the devices from this lot may not be completely sealed and sterility may be compromised
  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    sterility may be compromised