Smiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
Smiths Medical ASD, Inc. is recalling specific lots of 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity rating.
Plain-English summary
Smiths Medical ASD, Inc. is recalling specific lots of Portex Arterial Blood Sampling Line Draw Syringes. The recall is due to an issue with the plunger tip of the devices. These are sterile, single-use, in-vitro diagnostic devices used for drawing arterial blood via an arterial line and are not for injection.
The affected products are distributed worldwide, including in the United States and various international locations. The specific lots subject to the recall are identified by the following codes: 2485103, 2493959, 2498064, 2511207, 2521581, 2525780, 2525781, 2533316, 2547272, 2574207, 2578556, 2472508, 2476319, 2467728, and 2497730.
Healthcare facilities and consumers should check their inventory for these specific lot codes. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to the recall instructions.
The recalled product
- Product
- 4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro¿ device, 22g x 1¿ needle, and Point-Lok¿ needle safety device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices…
- 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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