FDA-Device2022-10-26Class II

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

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
9 boxes (900 syringes)
Manufactured in
Unit 2, Rivington View Business Park, Bolton, N/A, United Kingdom
Products
Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0107-2023

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