FDAJune 19, 2020device

PowerLoc MAX Power Injectable Infusion Port Access Kit; Catalog Numbers 2131910 (UDI 00801741044151), 2131915 (UDI 00801741044168), 2131975 (UDI 00801741044175), 2132010 (UDI 00801741044151), 2132015 (UDI 00801741044199), 2132075 (UDI 00801741044205), 2132210 (UDI 00801741044212), 2132275 (UDI 00...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard material (e.g., blood). A crack or break could result in potential blood loss, catheter occlusion, air embolism, under or interrupted infusion, or site contamination which could lead to infection.

What to do

FDA enforcement status: Terminated

Brands named

becton dickinsonbectonbecton dickinson

UPCs

008017410441510080174104416800801741044175008017410441990080174104420500801741044212008017410442360080174104424300801741044250008017410442670080174104427400801741044281

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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