The Recall Desk
HighFDA (Devices)·Z-1189-2014·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. The sterile, single-use devices are distributed worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a mechanical defect (plunger tip issue) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes, specifically the G1725 3 mL and 1 mL Line Draw Luer slip syringes with Filter-Pro devices. These sterile, single-use in-vitro diagnostic devices are used for drawing arterial blood via an arterial line and are not intended for injection.

The recall is being conducted due to an issue with the plunger tip of the syringes. The affected products were distributed worldwide, including in the United States and various international locations such as Australia, Canada, and several European countries.

Healthcare facilities and consumers should stop using the affected syringes and contact Smiths Medical ASD, Inc. for further instructions or a return.

The recalled product

Product
G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device and 1 mL Line Draw Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use
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)

  • 2530465 2530465

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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