Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
FDA device recall Z-1479-2018 · posted 2018-04-20 · Terminated
Recall details
- Recalling firm
- Medtronic Vascular
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 855 units
- Distribution
- US and AUSTRIA, Canada, Germany, ROMANIA, SLOVENIA,
- Date initiated
- 2018-03-13
- Date posted
- 2018-04-20
- Date terminated
- 2021-05-07
- Location
- Danvers, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak (K161287) | Medtronic Vascular | 2016-08-19 |