Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
Smiths Medical ASD, Inc. is recalling specific Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip. The devices are sterile, single-use, and 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 is classified as FDA Class II. Per the rubric, risk-of-harm products where injury has not yet been reported are assigned a score of 3 (High).
Plain-English summary
Smiths Medical ASD, Inc. is recalling 4043E: 3 mL Line Draw, Luer slip syringes (heparin concentration: 23.5 I.U. per mL) with 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 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 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 locations such as Australia, Canada, and several European countries. Specific lot codes are listed in the recall documentation. Users of these devices should contact Smiths Medical ASD, Inc. for further instructions on how to proceed.
The recalled product
- Product
- 4043E: 3 mL Line Draw, Luer slip 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 v
- 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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