Volcano TrakBack II Disposable Pullback Device; Sterile and nonpyrogenic; Single Use. TrakBack II is used to move the ca
FDA device recall Z-2636-2014 · posted 2014-09-12 · Terminated
Recall details
- Recalling firm
- Volcano Corporation
- Reason for recall
- Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
- Action taken
- Volcano sent an Urgent Product Recall Notification letter dated August 13, 2014, to all customers who received the device in the last 25 months. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease use of the affected product and return unused devices to the Volcano distribution center. Customers were asked to prepare the attached inventory log and then contact Volcano Customer Service at 800-228-4728, option 4 to arrange for return of any affected product in their inventory. A credit would be issued for any returned product. Customers with questions were asked to call 800-228-4728. For questions regarding this recall call 978-439-3586.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 8251 total devices (3777 US)
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina.
- Date initiated
- 2014-08-13
- Date posted
- 2014-09-12
- Date terminated
- 2015-06-30
- Location
- Rancho Cordova, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRAK BACK II (K003938) | Jomed, Inc. | 2001-01-18 |