The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0502-2015·Announced 2014-12-10

Aesculap Dual Switch Valve Recalled for Incorrect Expiration Date Labeling

Aesculap, Inc. is recalling three Dual Switch Valves due to incorrect expiration dates on inner sterile bag labels. No patient injuries have been reported.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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: The recall is classified as FDA Class II, but the source explicitly states no patient injuries were reported and the hazard is limited to a labeling error, fitting the Moderate criteria for minor labeling errors.

Plain-English summary

Aesculap, Inc. has initiated a recall of three units of the Miethke Shunt System, Dual Switch Valve. This medical device is used for fluid drainage from the ventricles into the peritoneum in cases of hydrocephalus.

The recall was initiated due to incorrect product labeling on the inner sterile bag, which displayed the wrong expiration date of 2024-09. The expiration date on the outer box was correct. The affected units are identified by Item Number FV129, Lot Number 4506244166, and Serial Number A10150. Distribution was limited to Kansas.

No patient injuries were reported as a result of this labeling issue. Healthcare providers and patients should verify the expiration date on the outer box and contact Aesculap, Inc. for further instructions regarding the affected units.

The recalled product

Product
The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.
Manufacturer
Aesculap, Inc.
Category
Medical Device — Neurological / Shunt
Hazard
Affected units
1

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)

  • Item Number FV129 Lot Number 4506244166 Serial Number A10150

Distribution

Distributed in 1 state:

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