Bio-Signal Group Recalls HydroDot Wave Prep Cups Due to B. cepacia Contamination
Bio-Signal Group Corp. is recalling HydroDot Wave Prep single-use cups due to potential contamination with Burkholderia cepacia. The product is distributed in six US states.
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) in a medical device without reported illnesses, which aligns with the rubric criteria for a High severity score.
Plain-English summary
Bio-Signal Group Corp. is recalling HydroDot brand Wave Prep single-use cups, 8.5 gm (0.3 oz), 24/box (Product 1700-24). The recall involves 45,375 individual cups, or 1,314 boxes, from Lot #s 29879, 29958, 30656, 31320, and 31365. The product is an electroconductive cream used with external electrodes to reduce contact impedance between the electrode surface and the skin.
The recall is being conducted because the product has the potential to be contaminated with Burkholderia cepacia (B. cepacia). The affected units were distributed nationwide in the states of California, Kentucky, Massachusetts, New Mexico, Pennsylvania, and Wisconsin.
Consumers who have purchased these specific lots of HydroDot Wave Prep cups should stop using the product and contact Bio-Signal Group Corp. for further instructions or a refund.
The recalled product
- 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 wit
- 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 (3)
- Lot # s 29879
- 29958
- 30656 Expanded: Lot # 31320 and Lot #31365
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 Electroconductive Cream
FDA (Devices) · 2019-12-25
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