The Recall Desk
ModerateFDA (Devices)·Z-1368-2015·Announced 2015-04-08

Quest Medical Recalls Lacrimal Intubation Sets Due to Labeling Error

Quest Medical is recalling 106 units of LIS27T Lacrimal Intubation Sets because the expiration date was incorrectly printed in the manufacturing date field.

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: The recall is classified as FDA Class II, and the hazard is a labeling error (mis-labeling) without reported injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Quest Medical, Inc. is recalling 106 units of the LIS27T Lacrimal Intubation Set. These sterile, prescription-only devices are used in various ophthalmology procedures. The recall involves specific lots, 40905AQ and 40601C.

The recall was initiated because the expiration date was incorrectly printed in the Manufacturing Date field on both the pouch and carton labels. This labeling error could potentially lead to the use of expired medical devices.

The affected products were distributed worldwide, including nationwide in the United States and in Ireland. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the affected sets if found.

The recalled product

Product
LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.
Affected units
106

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)

  • Lot 40905AQ and 40601C

Distribution

Distributed nationwide across the United States.

The notice also names 20 states specifically:

Same manufacturer · Quest Medical, Inc.

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