Recall Z-0114-2023— Medicina Uk Ltd

Name: FDA recall Z-0114-2023
Creator: U.S. Food and Drug Administration
Published: 2022-07-04

Class II · Ongoing

Class II FDA medical device recall by Medicina Uk Ltd, initiated 2022-07-04. FDA's recall record names no specific 510(k) clearance for this event. Product: Medicina Reusable Oral syringe 2.5ml Code: OTH25. Reason: Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification.

Recalling firm: Medicina Uk Ltd
Classification: Class II
Status: Ongoing
Initiated: 2022-07-04
Firm location: Bolton, N/A, United Kingdom

Product description

Medicina Reusable Oral syringe 2.5ml Code: OTH25

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.