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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

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

Agency Publication Date: October 20, 2022
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Affected Products

Product: Medicina Reusable Oral syringe 2.5ml Code: OTH25

UDI-DI: (01)05056115402876 Batch number: HM18042, HM21019, HM21054

Lot Numbers:
number
Product: Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD

UDI-DI: (01)05060278508146 Batch number: HM17121, HM18051, HM18080, HM18120, HM18141, HM19007, HM19016, HM19059, HM19083, HM19130, HM19144, HM20005, HM20054, HM21044, HM22018

Lot Numbers:
number
Product: Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05

UDI-DI: (01)05060278508153(17)250400(10)HM20055 Batch number: HM17099, HM18010, HM18052, HM18103, HM18113, HM18143, HM19009, HM19018, HM19061, HM19084, HM19132, HM19146, HM20006, HM20032, HM20055, HM20095, HM21037, HM21069, HM22019

Lot Numbers:
number
Product: Medicina Oral Tip Syringe 0.5ml Code: OT005

UDI-DI: (01)05060278503417 Batch number: HM19024

Lot Numbers:
number
Product: Medicina Oral Tip Syringe 1ml Code: OT01

UDI-DI: (01)05060278503424 Batch number: HM18147, HM19012, HM19025, HM19088, HM19164, HM20063 HM21015, HM21072

Lot Numbers:
number
Product: Medicina Oral Tip Syringe 2.5ml Code: OT25

UDI-DI:(01)05060278503431 Batch number: HM19026, HM19165, HM20019, HM20064, HM21061

Lot Numbers:
number
Product: Medicina Reusable Oral syringe 1ml Code: OTH01

UDI-DI: (01)05056115402869 (01)05056115402869(17)260700(10)HM21053 Batch number: HM18041, HM21053

Lot Numbers:
number
Product: Medicina Reusable Oral syringe 5ml Code: OTH05

UDI-DI: (01)05056115403491 (01)05056115403491(17)260700(10)HM21055 Batch number: HM18043, HM20020, HM21055

Lot Numbers:
number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90849
Status: Active
Manufacturer: Medicina Uk Ltd
Manufactured In: United Kingdom
Units Affected: 8 products (9 boxes (900 syringes); 1 box (100 syringes); 120 boxes (12,000 Syringes); 29 boxes (2900 syringes); 20 boxes (2000 syringes); 111 boxes (11,100 syringes); 26 boxes (2600 syringes); 20 boxes (2000 syringes))

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. 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. Refer to the openFDA terms of service for more information.