PlainRecalls
FDA Devices Moderate Class II Terminated

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-operati

Reported: July 25, 2018 Initiated: February 20, 2018 #Z-2480-2018

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Cardinal Health 200, LLC
Units Affected
8,928 kits total
Distribution
US Nationwide Distribution in the states of California.
Location
Waukegan, IL

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Cardinal Health 200, LLC. Units affected: 8,928 kits total.
Why was this product recalled? ▼
A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 25, 2018. Severity: Moderate. Recall number: Z-2480-2018.

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