Z-2440-2018 Class II Terminated
FDA device recall Z-2440-2018 was initiated by Canadian Hospital Specialties on June 11, 2018 and is designated Class II. Reason for recall: The product may be packaged with the incorrect length of feeding tube as labeled. The recall status is terminated (terminated March 13, 2019). Affected quantity: 10/10-tube cases.
Recall Details
- Product Type
- Devices
- Report Date
- July 25, 2018
- Initiation Date
- June 11, 2018
- Termination Date
- March 13, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10/10-tube cases
Product Description
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.
Reason for Recall
The product may be packaged with the incorrect length of feeding tube as labeled.
Distribution Pattern
Distribution was made to GA. The foreign recalling firm also distributed product to Canada.
Code Information
Lot #135137