Boston Scientific recall: Sterility Concern
Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
Why was Boston Scientific 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
2013040058
- Product
- Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 38969-664.
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 7
- Distribution
- TX and Russia
- Recall date
- March 19, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)