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 an issue with the plunger tip. The devices are used for in-vitro diagnostic blood sampling.
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 physical defect (plunger tip issue) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 4042-2: 3 mL Line Draw, Luer lock syringes with a Filter-Pro device. These are sterile, single-use, in-vitro diagnostic devices used for drawing arterial blood via an arterial line. The product is not for injection.
The recall is being issued due to an issue with the plunger tip of the Portex Arterial Blood Sampling Line Draw Syringes. The source text does not specify the exact nature of the defect or report any associated 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 the affected syringes and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- 4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The
- 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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