The FDA labeled a recall of integrated arterial catheters made by Medline Class I, the most serious kind of recall.
This recall involves removing certain devices from where they are used or sold. The company reports no injuries or deaths related to this recall to date, according to an FDA notice.
Medline designed its arterial catheter for continuously monitoring blood pressure and taking blood samples from patients. The company recalled the catheters due to a manufacturing issue that led to the presence of excess material on the catheter hub.
Use of a catheter with excess material at the hub could potentially lead to the material detaching. The material could then enter the body at the place of insertion or enter the bloodstream.
The use of affected product can lead to serious adverse health consequences. Those include the blockage of blood vessels (embolism) and death.
Medline issued a medical device recall letter for the catheters found in its Arterial Line Insertion kits, bundles, trays or insertion trays on Dec. 31, 2024. The company recommended that customers check stock immediately for affected item numbers and lot numbers. Customers should quarantine all affected product.
The company instructed users to remove the affected component before using the kit. It plans to include this instruction on the new label.
