medical Class II Updated 2018-07-25

Cardinal Health 200, LLC recalls Presource PBDS, Kit, Common Diabetes. Kit includes a exerci

Recalled Product

Presource PBDS, Kit, Common 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.


Hazard / Issue

A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Code SP1692448A (Lot Numbers 820353, 821937, 822523, 826984, 827083, 828090, 830102), Product Code SP1692448B (Lot Number 849805)
View official government recall

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