Medicina ENFit Enteral Syringes Recalled for Incorrect Plunger Material
Medicina Uk Ltd is recalling Medicina ENFit 5ml Reusable Enteral Syringes because the plunger component was manufactured with polyethylene instead of the specified polypropylene material.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses, injuries, or device failures. The material specification defect presents a potential safety concern but without evidence of actual harm to users.
Plain-English summary
Medicina Uk Ltd is recalling Medicina ENFit 5ml Reusable Enteral Syringes due to a manufacturing defect affecting the plunger component. The plunger was manufactured with polyethylene instead of the approved polypropylene material and does not meet the product's raw material specification.
The recalled syringes were distributed nationwide and include the following batch numbers: HM17099, HM18010, HM18052, HM18103, HM18113, HM18143, HM19009, HM19018, HM19061, HM19084, HM19132, HM19146, HM20006, HM20032, HM20055, HM20095, HM21037, HM21069, and HM22019. Affected products can be identified using the UDI code (01)05060278508153(17)250400(10)HM20055.
Healthcare facilities and providers using these syringes should discontinue use immediately and contact Medicina Uk Ltd regarding replacement or return of affected units. If you have questions about whether your product is affected, check the batch number on your syringe packaging.
The recalled product
- Product
- Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05
- Manufacturer
- Medicina Uk Ltd
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Medicina Uk Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same manufacturer · Medicina Uk Ltd
See all →- HighMedicina ENFit enteral syringe recall due to material specification defect
FDA (Devices) · 2022-10-26
- HighMedicina Oral Tip Syringe recalled for unapproved plunger material
FDA (Devices) · 2022-10-26
- HighReusable Oral Syringe Recalled for Unapproved Plunger Material
FDA (Devices) · 2022-10-26
- HighMedicina Oral Tip Syringe Recall Due to Unapproved Plunger Material
FDA (Devices) · 2022-10-26
- HighOral Tip Syringes Recalled Due to Unapproved Plunger Material
FDA (Devices) · 2022-10-26