Recall Z-1033-2016 ยท KNT Tubes, Gastrointestinal (And Accessories)
Covidien LLC
Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 6.5 Fr/Ch (2.2 mm) x 36" (91 cm), Sterile; Catalog Number: 461438. Intended for pediatric feeding.
| Date | Mar 2, 2016 (initiated Jan 21, 2016) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Labeling Change Control |
| Action | 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. |
| Quantity | 1,010 units |
| Distribution | Worldwide Distribution -- US, to the state of CA; and, to Australia and Europe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K820442 | ARGYLE INDWELL FEEDING TUBE Sherwood Medical Co., Mar 10, 1982 |