FDA recall Z-0705-2020

Product

HydroDot brand: Wave Prep Single use cups, 8.5 gm (0.3 oz) 24/box-Product 1700-24 - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin. The cream is not intended for use with stimulating electrodes.

Reason for recall

Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia)

Distribution

US Nationwide distribution in the states of CA, KY, MA, NM, PA, WI.

Key facts

Status

Terminated

Initiation date

2019-10-29

Report date

2019-12-25

Termination date

2021-09-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Acton, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0705-2020