Agency classClass IIIOur severity:Low FDA (Devices)·Z-1028-2015·Announced 2015-02-04

Smiths Medical Recalls Arterial Blood Sampling Kits Due to Labeling Error

Smiths Medical ASD, Inc. is recalling 900 units of Portex Anaerobic Pulsator Arterial Blood Sampling Kits because the inner unit label displays an expiration date one year later than the actual date.

The agency’s classification

FDA (Devices): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling error.

Plain-English summary

Smiths Medical ASD, Inc. is recalling 900 units of Portex Anaerobic Pulsator Arterial Blood Sampling Kits, Reorder Number G1392, Lot Number 2782094. These kits are intended for sampling arterial blood for the measurement of blood gases, cooximetry, electrolytes, total magnesium, and metabolites. The products were distributed in Florida.

The recall was initiated due to a labeling discrepancy. The outer box label correctly displays an expiration date of 08/2016. However, the inner Tyvek unit label is marked with 08-2017, which exceeds the actual expiration date by one year. This error could lead to the use of expired heparin or other components.

Healthcare facilities and consumers who have these specific units should stop using them and contact Smiths Medical ASD, Inc. for instructions on return or replacement. The agency has classified this as a Class III recall, indicating that use of the product is not likely to cause adverse health consequences.

The recalled product

Product: Portex Anaerobic Pulsator Arterial Blood Sampling Kit, with Liquid Sodium Heparin for Gases and Electrolytes. Reorder Number: G1392 Product Usage: The Arterial Blood Sampling Kit is intended for sampling arterial blood for the measurement of blood gasses, Cooximetry…
Manufacturer: Smiths Medical ASD, Inc.
Category: Medical Device — Blood Sampling
Hazard: mis-labeling
Affected units: 900

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 Number: 2782094

Distribution

Distributed in 1 state:

Same manufacturer · Smiths Medical ASD, Inc.

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