FDAClass IIDecember 25, 2019

HydroDot brand: Wave Prep Single use cups recall: Contamination

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…

Why was HydroDot brand: Wave Prep Single use cups recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # s 29879, 29958, 30656 Expanded: Lot # 31320 and Lot #31365

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…
Recalling firm
Bio-Signal Group Corp.
Quantity
45,375 individual cups Expanded:1314 boxes (24/box)
Distribution
US Nationwide distribution in the states of CA, KY, MA, NM, PA, WI.
Recall date
December 25, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls