The Recall Desk
ModerateFDA (Devices)·Z-1183-2014·Announced 2014-03-19

Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue

Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.

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 source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes, specifically the 4043G-2 model. These are sterile, single-use, in-vitro diagnostic devices used for drawing arterial blood via an arterial line. The product is not intended for injection.

The recall is being conducted due to an issue with the plunger tip of the syringes. The source text does not specify the nature of the defect or any reported injuries or illnesses.

The affected products were distributed worldwide, including in the United States and various international locations. Consumers and healthcare facilities should stop using these syringes and contact Smiths Medical ASD, Inc. for further instructions.

The recalled product

Product
4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and ice bag Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arter
Manufacturer
Smiths Medical ASD, Inc.
Category
Medical Device — Syringes
Hazard

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)

  • 2489881 2503429 2513713 2525788 2555872 2472514

Distribution

Distributed in 40 states:

Part of a larger recall action

This product is one of 13 recalled by Smiths Medical ASD, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

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