Medical device recalls Moderate risk

Canadian Hospital Specialties recalls MED-RX, Ref 54-1650R 5Fr X 16 inch (40cm) Polyurethane Feeding Tube For Pediatric Use with Orange Radiopaque Stripe and…

Recall date
June 11, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2440-2018
FDA classification
Class II
Brand / firm
Canadian Hospital Specialties
Sold / distributed
Distribution was made to GA. The foreign recalling firm also distributed product to Canada.

Why it was recalled

The product may be packaged with the incorrect length of feeding tube as labeled.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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