Agency classClass IIOur severity:High FDA (Devices)·Z-1188-2014·Announced 2014-03-19

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

Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to a reported issue with the plunger tip. The devices are sterile, single-use, in-vitro diagnostic tools used for drawing arterial blood.

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 3/5 (High).

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 criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Smiths Medical ASD, Inc. is recalling the G1469J 3 mL Line Draw, Luer slip syringe with Filter-Pro device. The recall is due to an issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes. These are sterile, single-use, in-vitro diagnostic devices used for drawing arterial blood via an arterial line and are not intended for injection.

The affected products were distributed worldwide, including in the United States and various international markets such as Australia, Canada, and several European countries. Specific lot codes associated with the recall include 2467804, 2480661, 2503528, 2503529, 2521653, 2529597, 2529598, 2551329, 2572218, 2572220, and 2467805.

Healthcare providers and consumers should stop using the affected syringes and contact Smiths Medical ASD, Inc. for further instructions or a replacement. The source text does not specify the exact nature of the plunger tip defect or report any specific injuries or illnesses associated with the use of these devices.

The recalled product

Product: G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Japan only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood…
Manufacturer: Smiths Medical ASD, Inc.
Category: Medical Device — Syringes
Hazard: mechanical-defect

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 →

Same manufacturer · Smiths Medical ASD, Inc.

See all →

Severe
CADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
FDA (Devices) · 2025-05-14
Severe
CADD-Solis Infusion Pump Thermal Damage Risk Recall
FDA (Devices) · 2025-05-14
Critical
CADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
Critical
CADD Solis HSPCA Pump wireless connection alarm interruption recall
FDA (Devices) · 2025-05-14
Critical
CADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14

Same hazard · mechanical defect