Natus Sleep Supplies Recalled for Conductive Adhesive Gel Quality Defects
Natus Neurology is recalling Sleep Supplies Start Kits due to defective conductive adhesive gel supplied by Parker Laboratories. The gel is too thick, discolored, and caused patient irritation in at least one case.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II voluntary precautionary recall with reported patient irritation but no serious injury or hospitalizations. The issues are primarily product quality defects (thickness, discoloration) affecting clinical function, consistent with the Moderate severity criterion for voluntary recalls.
Plain-English summary
Natus Neurology is recalling Sleep Supplies Start Kits with Single Use Supplies for Embla EX Series Amplifiers (REF 024252, Lot Numbers 614922, 614923, 614921, 122923, 628166) because they contain a conductive adhesive gel component supplied by Parker Laboratories Inc. The supplier's Tensive Conductive Adhesive Gel (Ref. 22-60, Lot Number A0623009) is the subject of a voluntary recall.
The gel has been reported to be too thick, discolored (darker than usual), and in one instance, patients reported irritation following procedures using the gel. Natus has received five complaints related to these quality issues.
The affected Sleep Supplies Start Kits have been distributed worldwide, including throughout the United States and Canada. Healthcare facilities and clinicians should immediately stop using affected units and contact Natus Neurology or Parker Laboratories for guidance regarding replacement or return options. Patients who experienced irritation or other adverse effects should consult their healthcare provider.
The recalled product
- Product
- natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252
- Manufacturer
- Natus Neurology Inc
- Affected units
- 35
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 (6)
- UDI/DI x
- Lot Numbers: 614922
- 614923
- 614921
- 122923
- 628166
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Natus Neurology Inc 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.
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