Becton Dickinson & Company recalls PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336),…

Recall date

June 19, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2670-2020

FDA classification

Class II

Brand / firm

Becton Dickinson & Company

Sold / distributed

Worldwide Distribution

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PowerLoc MAX Power Injectable Infusion Set; Catalog Numbers 0131910 (UDI 00801741047329), 0131915 (UDI 00801741047336), 0131975 (UDI 00801741047343), 0132010 (UDI 00801741047350), 0132015 (UDI 00801741047367), 0132075 (UDI 00801741047374), 0132210 (UDI 00801741047381), 0132215 (UDI 00801741047398), 0132275 (UDI 00801741047404), 0141910 (UDI 00801741047411), 0141915 (UDI 00801741047428), 0141975 (UDI 00801741047435), 0142010 (UDI 00801741047442), 0142015 (UDI 00801741047459), 0142075 (UDI 00801741047466), 0142210 (UDI 00801741047473), 0142215 (UDI 00801741047480), 0142275 (UDI 00801741047497)