Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm),
FDA device recall Z-1033-2016 · posted 2016-03-02 · Terminated
Recall details
- Recalling firm
- Covidien LLC
- Reason for recall
- 8FR 16 PVC tubes were packaged in a 6.5 FR 36 Polyurethane packs and 8FR 20 PVC tubes were packaged in an 8FR 20 Polyurethane packs
- Action taken
- Medtronic/Covidien Customers notified via an Urgent Medical Device Recall letter, dated January 22, 2016. The letter identifies the affected product, instructs customers to discontinue use and quarantine any of the product, and return all affected inventory. Customers are also to complete the "Recalled Product Return Form." Questions or concerns can be directed to a Medtronic representative or Customer Service at 800-882-5878.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- KNT
- Quantity affected
- 1,010 units
- Distribution
- Worldwide Distribution -- US, to the state of CA; and, to Australia and Europe.
- Date initiated
- 2016-01-21
- Date posted
- 2016-03-02
- Date terminated
- 2017-06-01
- Location
- North Haven, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARGYLE INDWELL FEEDING TUBE (K820442) | Sherwood Medical Co. | 1982-03-10 |