Medicina Uk Ltd Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
Brand
Medicina Uk Ltd
Lot Codes / Batch Numbers
UDI-DI: (01)05060278508146 Batch number: HM17121, HM18051, HM18080, HM18120, HM18141, HM19007, HM19016, HM19059, HM19083, HM19130, HM19144, HM20005, HM20054, HM21044, HM22018
Products Sold
UDI-DI: (01)05060278508146 Batch number: HM17121, HM18051, HM18080, HM18120, HM18141, HM19007, HM19016, HM19059, HM19083, HM19130, HM19144, HM20005, HM20054, HM21044, HM22018
Medicina Uk Ltd is recalling Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD due to Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026