medical Class II Updated 2020-07-29

Becton Dickinson & Company recalls PowerLoc MAX Power Injectable Infusion Set with GuardIVa Ant

Recalled Product

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 00801741085680)


Hazard / Issue

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.

Issued by

FDA

Distribution: Worldwide Distribution
Lot/Code Info: Catalog Numbers 2132010G (UDI 00801741095504), 2132015G (UDI 00801741095511), 2141910G (UDI 00801741095542), 2142010G (UDI 00801741085680), 2142015G (UDI 00801741085680), 2142210G (UDI 00801741085680). Lot Numbers: REDY0771 REDY2980 REEN1111 REEN4550 REER0529 REEN2070 REEP0993 REDX0120 REDW1093 REDW2530 REDX1388 REDY0772 REEN1112 REEN2779 REEP2910 REEQ4095 REER2358 REDX0188
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