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.
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 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
Distribution
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.
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