Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1519-2017·Announced 2017-03-29

Teleflex Recalls Non-Latex Nasopharyngeal Airways Due to Labeling Error

Teleflex Medical is recalling 7,600 units of Green Non-Latex Robertazzi Nasopharyngeal Airways due to a labeling error. The voluntary recall covers products distributed in the US, Canada, and Mexico.

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 due to a labeling error. According to the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under the Moderate severity category.

Plain-English summary

Teleflex Medical is voluntarily recalling 7,600 units of the Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130 and 123132. The recall was initiated on January 13, 2017, and was classified as Class II by the FDA. The reason for the recall is a labeling error.

The affected products are intended to provide a patent airway for patients with a blockage or potential blockage of the nasal cavity or nasopharynx. The specific lot numbers involved are 16A14 and 16A14. The products were distributed nationwide in the United States, as well as in Canada and Mexico.

The recall status is currently terminated. Consumers and healthcare providers should check their inventory for these specific catalog numbers and lot numbers. If the products are found, they should be returned to Teleflex Medical or the distributor.

The recalled product

Product: Teleflex Green Non-Latex Robertazzi Nasopharyngeal Airway, Catalog No. 123130 and 123132 Product Usage: To provide a patent airway for a patient with a blockage or potential blockage of the nasal cavity or nasopharynx.
Manufacturer: Teleflex Medical
Category: Medical Device — Airway Management
Hazard: mis-labeling
Affected units: 7,600

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/Batch Numbers 16A14 and 16A14

Distribution

Distributed nationwide across the United States.

The notice also names 31 states specifically:

Same manufacturer · Teleflex Medical

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