FDA-Device2022-10-26Class II

Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05

Medicina Uk Ltd
Hazard

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

Sold states
Nationwide
Affected count
1 box (100 syringes)
Manufactured in
Unit 2, Rivington View Business Park, Bolton, N/A, United Kingdom
Products
Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0108-2023

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