Covidien Force TriVerse Electrosurgical Devices, Product numbers FT3000 and FT3000DB, UDI 10884524000084 20884524000081;
FDA device recall Z-1446-2020 · posted 2020-02-25 · Terminated
Recall details
- Recalling firm
- Covidien Llc
- Reason for recall
- Sterile packaging may potentially be compromised, and use of products may result in increased risk for infection.
- Action taken
- On February 10, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were informed of the packaging issue and instructed to do the following: 1. Please immediately quarantine and discontinue use of the affected item codes and lots listed in the notice. 2. Please return affected product as indicated in the notice. All unused products from the affected item codes and lots must be returned. 3. If you have distributed Covidien Force TriVerse electrosurgical devices listed on Attachment A, please promptly forward the information from this letter to those recipients. 4. Complete the Recalled Product Return Form even if you do not have inventory. If you have any questions or concerns, please do not hesitate to contact your Medtronic representative or Customer Service at 800-962-9888, option 2.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GEI
- Quantity affected
- 70361
- Distribution
- Nationwide domestic distribution. Foreign distribution to Australia, Canada, Austria Belgium Canary Islands Czech Republic Denmark Finland France Germany Greece Hungary Italy Jordan Kazakhstan Kenya L
- Date initiated
- 2020-02-10
- Date posted
- 2020-02-25
- Date terminated
- 2024-04-26
- Location
- Mansfield, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Force TriVerse Electrosugical Device, Holster, 10-foot, Force TriVerse Electrosurgical Device, Holster, 15-foot (K150735) | Covidien | 2015-08-04 |