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 physical defect (plunger tip issue) where no injuries or illnesses have been reported, fitting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the 4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro device. These are sterile, single-use, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not 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 source text does not specify the nature of the defect or report any associated illnesses or injuries.
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 are listed in the recall documentation. Users should stop using the affected syringes and contact the manufacturer for further instructions.
The recalled product
- Product
- 4043-2: 3 mL Line Draw, Luer slip 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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