The FDA recently issued a warning letter to Cardinal Health
(NYSE: CAH)
following an inspection at one of its facilities.
The inspection revealed unapproved device violations pertaining to the Monoject Leur-lock tip syringes and the Monoject Enteral Feeding Syringes, as well as quality system regulation violations.
Dublin, Ohio-based Cardinal Health was found to be marketing convenience kits containing certain piston syringes manufactured by Jiangsu Shenli Medical Production Co. without appropriate FDA approvals. The FDA deemed the device adulterated and misbranded under various Federal Food, Drug, and Cosmetic Act sections.
According to the warning letter, syringes with different technological characteristics in the kits posed risks to patient safety, including dosing and device leakage.
Quality system regulation violations led to a recall
Cardinal Health’s quality system regulation violations included failure to establish and maintain procedures ensuring that all purchased or received products and services conform to specified requirements.
The inspection revealed that Cardinal Health’s procedure for outlining product requirements and conducting supplier qualification activities was not adequately established. The FDA said the deficiency resulted in a lack of data to demonstrate that product requirements were met during supplier qualification activities.
Specific product requirements outlined in the ISO Standard 7886-1:2017 were also not established in the product requirements document, and no data were received from the supplier to ensure compliance with the requirements, according to the FDA letter.
Since the company could not provide documentation supporting the use of Monoject syringes with infusion pumps, the company initiated a recall in December last year. The FDA labeled the recall as Class I, the most serious kind, and recommended product removal from the market.
How quality system violations resulted in numerous device recalls and removals
Cardinal Health initiated the recall on December 28, 2023. It affected Luer Lock devices distributed between June 1, 2023, and August 31, 2023, and the recalled Enteral Syringes distributed between September 1, 2023, and October 10, 2023.
The recall was initially a product correction but was later elevated to a product removal due to changes in manufacturing, resulting in different product dimensions, which led to compatibility issues when used with syringe pumps, patient-controlled analgesia (PCA) pumps, and enteral syringe feeding pumps.
Cardinal Health began distributing the Monject syringes under the Cardinal Health brand since the new syringes differed from the previously branded Covidien Monoject syringes with new dimensions and a different contract manufacturer.
However, the dimensional changes made to the Cardinal Health Monject syringes and the incompatibility could lead to pump performance issues, such as overdose, underdose, delay in therapy, delay in occlusion alarms and delay in feeding.
As of March 7, 2024, no reports of death related to the recall have been reported.
Cardinal Health’s recall led to a Class I recall of BD’s Alaris infusion pumps in December 2023. The recall cited compatibility issues with Cardinal Health’s Monoject syringes, mainly related to changes made to Cardinal Health’s products.
An FDA notice distributed in the Alaris recall said that Alaris pumps are validated for use with Monoject syringes and list it as an option when users select their syringe type. However, the updated syringes haven’t been validated for use with BD Alaris syringes and PCA modules.
BD said this issue led to over- and under-infusions, plus delays in therapy. The company received 13 reported injuries and no reports of death to date.
