{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "196044", "product_res_number": "Z-0108-2023", "event_date_initiated": "2022-07-04", "event_date_posted": "2022-10-20", "recall_status": "Open, Classified", "res_event_number": "90849", "product_code": "KYW", "product_description": "Medicina ENFit 5ml Reusable Enteral Syringe\n\nCode: LHE05", "code_info": "UDI-DI: (01)05060278508153(17)250400(10)HM20055\n\nBatch number: HM17099, HM18010, HM18052, HM18103, HM18113, HM18143, HM19009, HM19018, HM19061, HM19084, HM19132, HM19146, HM20006, HM20032, HM20055, HM20095, HM21037, HM21069, HM22019", "firm_fei_number": "3008432385", "recalling_firm": "Medicina Uk Ltd", "address_1": "Unit 2 Rivington View Business Park", "city": "Bolton", "country": "United Kingdom", "reason_for_recall": "Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification", "root_cause_description": "Nonconforming Material/Component", "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.\n .\nLetter states reason for recall, health risk and action to take:\n\nAction to be taken\n- Please carefully read this Field Safety Notice and return the Acknowledgement Form\n- Please do not use any of the batches of product listed on this notice\n- If you have product to return, please complete the information on the Acknowledgement Form and our team will arrange the return for you\n- Please distribute throughout your organisations and to relevant personnel\n- If you have any questions or queries in relation to this notice, please contact us using the information below\nContact information regarding FSN\nShaista Patel\nQA/RA Administrator\nUnit 2, Rivington View Business Park, Station Road, Blackrod, Bolton\nBL6 5BN\nEmail: quality.administrator@medicina.co.uk Tel: 01204 695050", "product_quantity": "1 box (100 syringes)", "distribution_pattern": 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