FDA Recall
Terminated
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.
Recall: Z-0725-2019
·
Initiated December 1, 2018
Recall
- Recall Number
- Z-0725-2019
- Event Number
- 81763
- Firm
- Canadian Hospital Specialties
- FEI Number
- 3932
- Product Code
- FPD
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- December 1, 2018
- Terminated
- April 2, 2021
- Address
- 2760 Brighton Rd, Oakville Canada
Description
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.
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.
Action
The firm notified its consignees of the recall by email on 12/01/2018. The letter identified the affected product, problem and actions to be taken. The firm requested return of the product.
Distribution
US in the states of TN
Quantity
75 cases of 10