FDA (Devices) recall action 64736
The FDA (Devices) publishes a recall like this one as 14 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 14 pages.
Various Presource Kits contain a pre-assembled Filter and Anesthesia Circuit that may contain outer plastic packaging on one or more components. If the packaging is removed without disassembling the components, remnants of the plastic from the packaging material may become lodged in the filter potentially causing an obstruction of airflow.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Cardinal Health is recalling 4,571 Presource Total Hip Kits because plastic packaging remnants may obstruct airflow in the filter.
Cardinal Health is recalling 4,571 Presource Total Knee Kits because plastic packaging remnants may obstruct airflow in the filter.
Cardinal Health is recalling 4,571 Presource Knee Arthroscopy Kits because plastic packaging remnants may lodge in the filter and obstruct airflow.
Cardinal Health is recalling Presource PBDS Anesthesia Circuit Kits because plastic packaging remnants may lodge in the filter and obstruct airflow.
Cardinal Health is recalling Presource Knee Arthroscopy Kits because plastic packaging remnants may lodge in the filter, potentially obstructing airflow.
Cardinal Health is recalling 4,571 Presource PBDS kits because plastic packaging remnants may lodge in the filter and obstruct airflow.
Cardinal Health is recalling 4,571 Presource Lap Chole Kits because plastic packaging remnants may lodge in the filter and obstruct airflow.
Cardinal Health is recalling Presource Total Joint Kits because plastic packaging remnants may obstruct airflow in the filter.
Cardinal Health is recalling 4,571 Presource PBDS Extremity Circulator Kits because plastic packaging remnants may obstruct airflow.
Cardinal Health is recalling 4,571 Presource PBDS General Laparoscopy Kits because plastic packaging remnants may obstruct airflow in the filter.
Cardinal Health is recalling 4,571 Presource Major Abdominal Kits because plastic packaging remnants may lodge in the filter and obstruct airflow.
Cardinal Health is recalling 4,571 Presource Shoulder Procedure Kits because plastic packaging remnants may obstruct airflow in the filter.
Cardinal Health is recalling 4,571 Presource Shoulder Arthroscopy Kits because plastic packaging remnants may obstruct airflow in the filter.
Cardinal Health is recalling 4,571 Presource Gyn Laparoscopy Kits because plastic packaging remnants may lodge in the filter and obstruct airflow.