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Open, Classified

Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05

FDA Recall Z-0108-2023 · Posted 2022-10-20

Recalling FirmMedicina Uk Ltd
Recall StatusOpen, Classified
Product CodeKYW
Date Initiated2022-07-04
Product Quantity1 box (100 syringes)

Reason for Recall

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

Firm Action

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: [email protected] Tel: 01204 695050

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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