Cardinal Health 200, Llc

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

Cardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unexpected variability of endotoxin levels on the products.

The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes contained within the packages are U-100 Insulin syringes.

The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.