Smiths Medical Recalls Arterial Blood Sampling Line Draw Syringes
Smiths Medical ASD, Inc. is recalling specific arterial blood sampling syringes due to a defect in the plunger tip.
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 2/5 (Moderate).
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 specific injuries, illnesses, or fatalities, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Smiths Medical ASD, Inc. is recalling G1762 3 mL Line Draw, Luer lock syringes with Filter-Pro devices, syringe tip caps, and 5 mL Luer lock syringes. 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 Portex Arterial Blood Sampling Line Draw 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 these specific syringes and contact Smiths Medical ASD, Inc. for further instructions or a replacement.
The recalled product
- Product
- G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, syringe tip cap, and 5 mL Luer lock syringe Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing…
- 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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