Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
Smiths Medical ASD, Inc. is recalling G2001 Arterial Blood Sampling Line Draw Syringes due to an 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 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 hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity recall involving a potential defect without confirmed harm.
Plain-English summary
Smiths Medical ASD, Inc. is recalling G2001 3 mL Line Draw, Luer slip syringes with Filter-Pro and Needle-Pro devices. These sterile, single-use in-vitro diagnostic devices are used for drawing arterial blood via an arterial line and are not for injection. The recall is 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. The specific lot code associated with this recall is 2548332.
Healthcare facilities and consumers should stop using these syringes immediately. Users should contact Smiths Medical ASD, Inc. for further instructions on how to return or dispose of the affected devices.
The recalled product
- Product
- G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, Needle-Pro¿ Device and 23G x 1 needle Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of…
- 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)
- 2548332
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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