Z-0705-2020 Class II Terminated
FDA device recall Z-0705-2020 was initiated by Bio-Signal Group Corp. on October 29, 2019 and is designated Class II. Reason for recall: Product has the potential to be contaminated with Burkholderia cepacia (B. cepacia) The recall status is terminated (terminated September 7, 2021). Affected quantity: 45,375 individual cups Expanded:1314 boxes (24/box).
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2019
- Initiation Date
- October 29, 2019
- Termination Date
- September 7, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45,375 individual cups Expanded:1314 boxes (24/box)
Product Description
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 Pattern
US Nationwide distribution in the states of CA, KY, MA, NM, PA, WI.
Code Information
Lot # s 29879, 29958, 30656 Expanded: Lot # 31320 and Lot #31365