Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes due to an issue with the plunger tip.
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 3/5 (High).
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 mechanical defect (plunger tip issue) where the specific risk of harm is not explicitly quantified in the source text, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD, Inc. is recalling Portex Arterial Blood Sampling Line Draw Syringes, specifically the 4042LH model. These are sterile, single-use, in-vitro diagnostic devices used for drawing arterial blood via an arterial line. The product is not intended for injection.
The recall is being issued due to an issue with the plunger tip of the syringes. The specific nature of the defect or the potential clinical consequences are not detailed in the provided source text.
The affected products were distributed worldwide, including in the United States and various international markets. Consumers and healthcare facilities should stop using these syringes and contact Smiths Medical ASD, Inc. for further instructions or a replacement.
The recalled product
- Product
- 4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 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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