Recall Z-2636-2014— Volcano Corporation
Class II · Terminated
Class II FDA medical device recall by Volcano Corporation, initiated 2014-08-13, terminated 2015-06-30. It names one FDA 510(k) clearance: K003938. Product: Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.. Reason: Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product..
- Recalling firm
- Volcano Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-08-13
- Terminated
- 2015-06-30
- Firm location
- Rancho Cordova, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.
Reason for recall
Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
Data sourced from openFDA. This site is unofficial and independent of the FDA.