Agency classClass IIOur severity:Low FDA (Devices)·Z-1105-2017·Announced 2017-02-01

Smiths Medical Recalls NORMFlow H-1100 Irrigation Fluid Warmer for Labeling Errors

Smiths Medical is recalling one NORMFlow H-1100 Irrigation Fluid Warmer in Sweden due to incorrect Spanish labels instead of English.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is for a labeling error (Spanish instead of English) with no reported injuries or illnesses, fitting the 'Low' severity criteria for documentation or packaging-only problems.

Plain-English summary

Smiths Medical ASD, Inc. is recalling one (1) NORMFlow H-1100 Irrigation Fluid Warmer, Model H-1100, Reorder H-1100-INT-230. The device is designed for the safe, in-line warming of irrigating fluids administered to patients in clinical situations requiring rapid irrigation.

The recall was initiated because the unit was incorrectly labeled with Spanish language labels instead of English labels. Specifically, five (5) labels were incorrect: the Operator's Manual, the Outer Base Box label, the Pole Assembly Box label, and two (2) O-ring Lube labels.

The affected unit was distributed in the foreign country of Sweden. The source text does not specify further instructions for consumers or healthcare providers regarding the disposition of the device.

The recalled product

Product: NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230. Product Usage: NORMOFLO¿ H-1100 Irrigation Fluid Warmers has been designed for safe, in-line warming of irrigating fluids as they are administered to patients. The Fluid Warmer…
Manufacturer: Smiths Medical ASD, Inc.
Category: Medical Device — Irrigation Fluid Warmer
Hazard: mis-labeling
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)

S105B0061

Distribution

Distribution scope not specified by the agency.

Same manufacturer · Smiths Medical ASD, Inc.

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Same hazard · mis labeling