Volcano TrakBack II Disposable Pullback Device recall: Sterility Concern
Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely…
Why was Volcano TrakBack II Disposable Pullback Device recalled?
Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
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?
Part number 91003: All Lots
- Product
- Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely…
- Recalling firm
- Volcano Corporation
- Quantity
- 8251 total devices (3777 US)
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina.
- Recall date
- September 24, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)