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Cardinal Health 200, LLC recalls Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin pr
Recalled July 25, 2018 · FDA recall Z-2483-2018 · Cardinal Health 200
Hazard
A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit. · FDA Class II
Units
8,928 kits total
Sold at
US Nationwide Distribution in the states of California.
Description
A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.
Product
Presource PBDS, Kit, No Spiro Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative complications, 2) up to two items of cloth, skin prep 2% CHG, a packet of for chlorhexidine gluconate antiseptic cloths utilized by the patient to reduce the risk of surgical site infections by wiping the body in a prescribed manner, 3) up to two Gatorade to help restore the body s electrolytes when fasting prior to surgery.
Manufacturer(s)
Cardinal Health 200, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →