Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0597-2019·Announced 2018-12-19

COVIDIEN Recalls Salem Sump Stomach Tubes Due to Packaging Error

COVIDIEN LLC is voluntarily recalling 1,522 Salem Sump Dual Lumen Stomach Tubes because one lot of 10 Fr tubes was incorrectly packaged in 16 Fr pouches.

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 and involves a packaging error that could affect patient care, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

COVIDIEN LLC is conducting a voluntary recall of 1,522 units of Salem Sump Dual Lumen Stomach Tubes, Product Code 8888264911. The affected product is the 10 Fr/Ch (3.3 mm) x 36" (91 cm) size. The recall is due to incorrect packaging where the 10 Fr product was placed in a 16 Fr pouch.

The agency classifies this as a Class II recall. The hazard is that a user might select a 10 Fr tube when a 16 Fr tube is clinically required. This error could result in decreased fluid collection, potentially affecting patient care, particularly in emergency situations where the correct size is not readily available.

The affected units were distributed worldwide, including US Nationwide and Canada. The source text does not specify specific healthcare facilities or patient counts. Users should verify the packaging of their Salem Sump tubes to ensure the size matches the product code and intended use.

The recalled product

Product: Salem Sump Dual Lumen Stomach Tube 10 Fr/Ch (3.3 mm) x 36" (91 cm), Product Code 8888264911 Product Usage: The Salem Sump Tubes are intended for decompression and drainage of stomach contents following injury, illness, or surgery in patients with intestinal obstruction, and…
Manufacturer: COVIDIEN LLC
Category: Medical Device — Gastrointestinal Tubes
Hazard: mis-labeling
packaging-error
Affected units: 1,522

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)

1812115564

Distribution

Distributed nationwide across the United States.

Same manufacturer · COVIDIEN LLC

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