Device product
MED-RX POLYURETHANE FEEDING TUBE For Pediatric Use with Orange Radioplaque Stripe and Enteral Connector, 6.5Fr X 24" (60cm), REF 54-2465-R Product Usage: A Nasogastric/Oralgastric enteral feeding tube. The MED-RX Feeding Tube is intended to be used for nasogastric/oralgastric enteral feeding as directed by a physician.
Z-0725-2019
Product summary
- Event
- Event 81763
- Status
- Terminated
- Classification
- Class II
- Quantity
- 75 cases of 10
- Official record key
device-enforcement:Z-0725-2019
Official wording
Reason: The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled.
Code information: Lot 139457
Distribution pattern: US in the states of TN
Derived failure modes
-
Unknown
The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled.