PlainRecalls
FDA Devices Moderate Class II Terminated

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 00801741044236), 2141910 (UDI 00801741044243), 2141915 (UDI 00801741044250), 2141975 (UDI 00801741044267), 2142010 (UDI 00801741044274), 2142015 (UDI 00801741044281), 2142075 (UDI 00801741044298), 2142210

Reported: July 29, 2020 Initiated: June 19, 2020 #Z-2662-2020

Product Description

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 00801741044236), 2141910 (UDI 00801741044243), 2141915 (UDI 00801741044250), 2141975 (UDI 00801741044267), 2142010 (UDI 00801741044274), 2142015 (UDI 00801741044281), 2142075 (UDI 00801741044298), 2142210 (UDI 00801741044304), 2142215 (UDI 00801741044311), 2142275 (UDI 00801741044328)

Reason for Recall

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.

Details

Units Affected
5,296,132 total
Distribution
Worldwide Distribution
Location
Franklin Lakes, NJ

Frequently Asked Questions

What product was recalled?
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 00801741044236), 2141910 (UDI 00801741044243), 2141915 (UDI 00801741044250), 2141975 (UDI 00801741044267), 2142010 (UDI 00801741044274), 2142015 (UDI 00801741044281), 2142075 (UDI 00801741044298), 2142210 (UDI 00801741044304), 2142215 (UDI 00801741044311), 2142275 (UDI 00801741044328). Recalled by Becton Dickinson & Company. Units affected: 5,296,132 total.
Why was this product 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.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 29, 2020. Severity: Moderate. Recall number: Z-2662-2020.