Medical device recalls Moderate risk

Medicina Uk Ltd recalls Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD

Recall date
July 4, 2022
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0107-2023
FDA classification
Class II
Brand / firm
Medicina Uk Ltd
Sold / distributed
Nationwide

Why it was recalled

Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

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

What was recalled

Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD

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