Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05

FDA device recall Z-0108-2023 · posted 2022-10-20 · Open, Classified

Recall details

Recalling firm

Medicina Uk Ltd

Reason for recall

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

Action taken

Medicina Ltd issued Field Safety Corrective Action notice to the US Distributor 07/04/2022 via email. The US Distributor is conducting recall to the user level letter issued the week of July 25th via United States Postal Service. . Letter states reason for recall, health risk and action to take: Action to be taken - Please carefully read this Field Safety Notice and return the Acknowledgement Form - Please do not use any of the batches of product listed on this notice - If you have product to return, please complete the information on the Acknowledgement Form and our team will arrange the return for you - Please distribute throughout your organisations and to relevant personnel - If you have any questions or queries in relation to this notice, please contact us using the information below Contact information regarding FSN Shaista Patel QA/RA Administrator Unit 2, Rivington View Business Park, Station Road, Blackrod, Bolton BL6 5BN Email: quality.administrator@medicina.co.uk Tel: 01204 695050

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

KYW

Quantity affected

1 box (100 syringes)

Distribution

Nationwide

Date initiated

2022-07-04

Date posted

2022-10-20

Location

Bolton, United Kingdom