Bio-Signal Group Recalls HydroDot Wave Prep Electroconductive Cream
Bio-Signal Group Corp. is recalling HydroDot Wave Prep electroconductive cream due to potential contamination with Burkholderia cepacia.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk pathogen (Burkholderia cepacia) without reported illness, which corresponds to a High severity score per the rubric.
Plain-English summary
Bio-Signal Group Corp. is recalling 1,500 tubes of HydroDot brand Wave Prep 4 oz. tubes (Product 1710-03). The product is an electroconductive cream used with external electrodes to reduce skin impedance.
The recall was initiated because the product has the potential to be contaminated with Burkholderia cepacia (B. cepacia). The affected units include Lot # 29688 and Lot # 31160. The products were distributed nationwide in California, Kentucky, Massachusetts, New Mexico, Pennsylvania, and Wisconsin.
Consumers should stop using the recalled product and contact Bio-Signal Group Corp. for further instructions.
The recalled product
- Product
- HydroDot brand: Wave Prep 4 oz. tubes-Product 1710-03. An electroconductive cream for use with external electrodes - Product Usage: An electroconductive cream for use with external electrodes to reduce the impedance of the contact between the electrode surface and the skin.
- Manufacturer
- Bio-Signal Group Corp.
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Product 1710-03: Lot # 29688 Expanded: Lot # 31160
Distribution
Part of a larger recall action
This product is one of 2 recalled by Bio-Signal Group Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Bio-Signal Group Corp.
See all →- HighBio-Signal Group Recalls HydroDot Wave Prep Cups Due to B. cepacia Contamination
FDA (Devices) · 2019-12-25
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