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

Medicina Uk Ltd: Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD

Is my product affected?

Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD

  • UPC 05060278508146

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

What happened

Medicina UK Ltd has recalled Medicina ENFit 1ml Reusable Low Dose Enteral Syringes because the plunger component was manufactured with polyethylene instead of the approved polypropylene material, which means it does not meet the required raw material specification. The recall affects 9 boxes containing 900 syringes that were distributed nationwide, with batch numbers ranging from HM17121 through HM22018.

The source document does not specify what action affected consumers should take in response to this recall.

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: 9 boxes (900 syringes) Lot/code info: UDI-DI: (01)05060278508146 Batch number: HM17121, HM18051, HM18080, HM18120, HM18141, HM19007, HM19016, HM19059, HM19083, HM19130, HM19144, HM20005, HM20054, HM21044, HM22018

Source

Official record: FDA (Device enforcement) ↗

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

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