FDAJune 19, 2020device

PowerLoc MAX Power Injectable Infusion Set with GuardIVa Antimicrobial Hemostatic Dressing Port Access Kit; Catalog Numbers 2132010G (UDI 00801741095504), 2132015G (UDI 00801741095511), 2141910G (UDI 00801741095542), 2142010G (UDI 00801741085680), 2142015G (UDI 00801741085680), 2142210G (UDI 0080...

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

00801741095504008017410955110080174109554200801741085680

Recall history

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

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