Device product
Covidien Kangaroo Polyurethane Feeding Tube Radiopaque Line, Safe Enteral Connections 8 Fr/Ch (2.7 mm) x 20" (51 cm); Catalog Number: 461701. Intended for pediatric feeding.
Z-1034-2016
Product summary
- Firm
- Covidien LLC
- Event
- Event 73115
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,330 units
- Official record key
device-enforcement:Z-1034-2016
Official wording
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
Code information: Lot Code: 521808064X
Distribution pattern: Worldwide Distribution -- US, to the state of CA; and, to Australia and Europe.
Derived failure modes
-
Unknown
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