Hidrex Recalls Daavlin Aquex Devices Due to Documentation Requirements
Hidrex GmbH is recalling 250 Daavlin Aquex (DAAV1000) devices nationwide because the device was reclassified from Class III to Class II, triggering new documentation requirements.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is driven by administrative documentation requirements following a device reclassification, which aligns with the rubric's definition of Low severity for documentation issues.
Plain-English summary
Hidrex GmbH is recalling 250 units of the Daavlin Aquex (DAAV1000) device. The affected units have serial numbers ranging from 16-3.8001 to 16-3.8250 and were distributed nationwide throughout the US.
The recall was initiated because the device was reclassified from a Class III device to a Class II device. This reclassification has resulted in new documentation requirements that necessitate the recall action.
Consumers who possess these specific serial numbers should contact Hidrex GmbH for further instructions regarding the recall and the updated documentation.
The recalled product
- Product
- Daavlin Aquex (DAAV1000)
- Manufacturer
- Hidrex GmbH
- Category
- Medical Device — Ophthalmic
- Hazard
- Affected units
- 250
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)
- SN# 16-3.8001 to 16-3.8250
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Hidrex GmbH 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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