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FDA (Device enforcement)Recalled 2024-10-18class ii

HUMAN MED AG: human med Biofill Infiltration Cannula, diameter 2.5mm, 15cm, REF 2024-012, REF 1580107, sterile, single use.

Hazard

The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet.

Details from the source

Reason for recall: The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spray jet. Distribution: US Nationwide distribution in the state of FL. Quantity: 775 devices Lot/code info: Lot number 24-20198, UDI (01)04260170881014(11)240611(17)270611(10)24-20198; and Lot number 23-19612, UDI (01)04260170881014(11)240109(17)270109(10)23-19612.

UPC codes

04260170881014

Source

Official record: FDA (Device enforcement)

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

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