Smiths Medical Recalls Portex Arterial Blood Sampling Syringes with Broken Luer
Smiths Medical ASD, Inc. is recalling Portex LineDraw Arterial Blood Sampling Syringes because the luer connectors may be broken.
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 defect (broken luer) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Smiths Medical ASD, Inc. is recalling Portex LineDraw Arterial Blood Sampling Syringes with Dry Lithium Heparin for Gases and Electrolytes. The recall involves 720,100 devices distributed across 33 U.S. states and internationally in Canada, Germany, and Australia.
The recall was initiated because the syringes may have broken luer connectors. The affected products include specific item numbers 4042-2 and 4042LH associated with lot numbers 3848838, 3848878, 3856950, 3859774, 3856958, and 3859747.
Healthcare facilities and consumers should stop using the affected syringes and contact Smiths Medical ASD, Inc. for further instructions or a replacement.
The recalled product
- Product
- Portex LineDraw Arterial Blood Sampling Syringe with Dry Lithium Heparin for Gases and Electrolytes
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 720,100
Distribution
Part of a larger recall action
This product is one of 2 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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