Arrow MAC Venous Catheter Kit Recall Issued Over Risk of Leaks, Bleeding and Death
Federal regulators warn the risk of a cross-lumen leak caused by inadequate connections qualifies the Arrow MAC Venous Catheter Kit recall for a Class I recall designation.
A Class I catheter recall has been announced by federal safety officials, after the manufacturer Arrow International identified a design defect which may cause the catheter connections to leak, posing a series of potentially fatal adverse health consequences to patients.
The Arrow MAC Venous Catheter Kit recall was announced by the U.S. Food and Drug Administration (FDA) on December 16, warning healthcare professionals to stop using certain Arrow MAC Two-Lumen Central Venous Access Kit due to the risk of serious bleeding events or delays in treatment.
The recalled catheters are intended to provide short term venous access and catheter introduction to the central circulation for the protection against catheter-related bloodstream infections.
According to the announcement, the catheters are being recalled due to the risk of a cross-lumen leak caused by inadequate connections between the top and bottom housings of the Micro Clave Clear Connectors included in the kits.
Officials warn that if the connections are defective, patients could be at an increased risk of experiencing fluid leakage, bleeding events, delayed treatment, infection and air entering the blood vessels, all of which could pose potentially life threatening risks to users.
Class I Catheter Recall
Due to the severity of the potential health consequences, the FDA has categorized the recall with its Class I status, indicating it is the most serious of its kind, and the use of the product has a high probability of resulting in serious injury or death.
The recall includes the Arrow MAC Two-Lumen Central Venous Access Kits; Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen Central Venous Catheter (CVC) Kits manufactured by Teleflex and their subsidiary Arrow International, LLC. Approximately 1,355 catheter kits are included in the recall that were distributed to healthcare facilities across the U.S. from March 8, 2022 through May 13, 2022.
Customers are being instructed to stop using the recalled Arrow catheters immediately to prevent the possibility of patient injury or death.
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Learn MoreTeleflex and Arrow International, LLC issued an Urgent Medical Device Recall letter on October 27, 2022, instructing customers to quarantine any remaining inventory, and provided instructions on how to return the recalled catheters to Teleflex Inc. for a refund.
Customers with additional questions or concerns regarding the recall are encouraged to contact Teleflex customer service at 866-396-2111 or email recalls@teleflex.com. The FDA is asking for all adverse reactions or quality problems related to the catheters to be reported to the agency’s Safety Information and Adverse Event Reporting Program.
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