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FDA (Device enforcement)Recalled 2022-07-04class ii

Medicina Uk Ltd: Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05

Is my product affected?

Medicina ENFit 5ml Reusable Enteral Syringe Code: LHE05

  • UPC 05060278508153

Check against the official notice below — it lists the full affected range.

What happened

Medicina UK Ltd is recalling Medicina ENFit 5ml Reusable Enteral Syringes due to a manufacturing defect in the plunger component. The plunger was made from Polyethylene instead of the approved material Polypropylene, which means it does not meet the product's raw material specifications. The recall affects one box containing 100 syringes distributed nationwide, with multiple batch numbers ranging from HM17099 through HM22019.

The source document does not specify a remedy or what affected consumers should do.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

Reason for recall: Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification Distribution: Nationwide Quantity: 1 box (100 syringes) Lot/code info: 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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