Recalls / —
—#162735
Product
Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
- FDA product code
- DQO — Catheter, Intravascular, Diagnostic
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K161287
- Affected lot / code info
- UDI 20643169689309, Lot Number 60074805
Why it was recalled
The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, information and configuration details.
Root cause (FDA determination)
Packaging
Action the firm took
Medtronic initiated consignee communications on 13-Mar- 2018 to Risk Managers and Health Care Professionals. US notifications were sent via 2-Day UPS delivery. OUS communications were sent per locally approved methods. Consignees are asked to quarantine and return any unused potentially affected product to Medtronic.
Recalling firm
- Firm
- Medtronic Vascular
- Address
- 35-37A Cherry Hill Drive, Danvers, Massachusetts 01923-2565
Distribution
- Distribution pattern
- US and AUSTRIA, Canada, Germany, ROMANIA, SLOVENIA,
Timeline
- Recall initiated
- 2018-03-13
- Posted by FDA
- 2018-04-20
- Terminated
- 2021-05-07
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #162735. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.