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 sterile, single-use 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 physical defect (plunger tip issue) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 4042E 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 any reported injuries or illnesses associated with the issue.
The affected products were distributed worldwide, including in the United States and various international markets. Specific lot codes are listed in the recall documentation. Consumers and healthcare facilities should check their inventory for the specific lot codes and stop using the affected syringes if they match the recalled items.
The recalled product
- Product
- 4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device (for sale in Europe 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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