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.
This recall has been terminated (originally issued July 13, 2018).
- Company
- Canadian Hospital Specialties
- Recall Initiated
- June 11, 2018
- Posted
- July 13, 2018
- Terminated
- March 13, 2019
- Recall Number
- Z-2440-2018
- Quantity
- 10/10-tube cases
- Firm Location
- Oakville Canada
- Official Source
- View on FDA website ↗
Reason for Recall
The product may be packaged with the incorrect length of feeding tube as labeled.
Distribution
Distribution was made to GA. The foreign recalling firm also distributed product to Canada.
Lot / Code Info
Lot #135137
Root Cause
Process control
Action Taken
The recalling firm issued a letter dated 6/1/2018 via email on 6/11/2018 to formally notify their customer of the reason for recall, discontinue distribution of the product, and complete the enclosed Product Recall Response Form for return via email.