FDA recall Z-2440-2018

Canadian Hospital Specialties · Class II · 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.

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.

Key facts

Status
Terminated
Initiation date
2018-06-11
Report date
2018-07-25
Termination date
2019-03-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Oakville, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2440-2018