Smiths Medical Recalls Arterial Blood Sampling Kits with Broken Luer Defect
Smiths Medical is recalling Portex Pro-Vent Arterial Blood Sampling Kits because some lots may have broken luer connectors.
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 defect (broken luer) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Smiths Medical ASD, Inc. is recalling specific lots of Portex Pro-Vent Arterial Blood Sampling Kits with Dry Lithium Heparin for Gases and Electrolytes. The recall involves 127,700 total devices distributed across 33 U.S. states and internationally in Canada, Germany, and Australia.
The recall was initiated because lots of the affected syringes may have broken luer connectors. The source text does not specify the exact clinical consequences of this defect or report any specific injuries or illnesses.
Healthcare facilities and consumers should stop using the affected lots and contact Smiths Medical for further instructions. The specific item numbers and lot numbers involved are listed in the official recall documentation.
The recalled product
- Product
- Portex ProVent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- Affected units
- 127,700
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Smiths Medical ASD, Inc.
See all →- SevereCADD Solis VIP Ambulatory Infusion Pump Thermal Damage Recall
FDA (Devices) · 2025-05-14
- SevereCADD-Solis Infusion Pump Thermal Damage Risk Recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis Ambulatory Infusion Pump False Alarm Malfunction
FDA (Devices) · 2025-05-14
- CriticalCADD Solis HSPCA Pump wireless connection alarm interruption recall
FDA (Devices) · 2025-05-14
- CriticalCADD-Solis VIP Ambulatory Infusion Pump False Occlusion Alarm Recall
FDA (Devices) · 2025-05-14
Same hazard · broken luer
See all →- HighVeritas Advanced Infusion Packs Recalled for Broken Irrigation Luer
FDA (Devices) · 2022-10-19
- HighSmiths Medical Recalls Portex Arterial Blood Sampling Syringes with Broken Luer
FDA (Devices) · 2020-04-22
Similar recalls
- HighSmiths Medical Blood Sampling Kits Missing Critical Filter Component
FDA (Devices) · 2023-11-01
- LowSmiths Medical Recalls Mislabeled Arterial Blood Sampling Kits
FDA (Devices) · 2018-09-26
- LowSmiths Medical Recalls Arterial Blood Sampling Kits Due to Labeling Error
FDA (Devices) · 2015-02-04
- ModerateSmiths Medical Recalls Arterial Blood Sampling Syringes Due to Plunger Tip Issue
FDA (Devices) · 2014-03-19
- ModerateSmiths Medical Recalls Arterial Blood Sampling Line Draw Syringes
FDA (Devices) · 2014-03-19
- ModerateSmiths Medical Recalls Arterial Blood Sampling Kits with Povidone Iodine Pads
FDA (Devices) · 2019-02-27