Device product
MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and Enteral Connector, packaged 10/case, Sterile, RX. The firm name on the label is chs, Oakville, ON, Canada.
Z-2440-2018
Product summary
- Event
- Event 80374
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10/10-tube cases
- Official record key
device-enforcement:Z-2440-2018
Official wording
Reason: The product may be packaged with the incorrect length of feeding tube as labeled.
Code information: Lot #135137
Distribution pattern: Distribution was made to GA. The foreign recalling firm also distributed product to Canada.
Derived failure modes
-
Unknown
The product may be packaged with the incorrect length of feeding tube as labeled.