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Recall Observatory FDA recall evidence

Device 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.

Z-2483-2018

February 20, 2018

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 80289
Status
Terminated
Classification
Class II
Quantity
8,928 kits total
Official record key
device-enforcement:Z-2483-2018

Official wording

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

Code information: Product Code SP4692448A (Lot Numbers 820354, 821943, 826374, 833181). Product Code SP4692448B (Lot Number 849841, 855450).

Distribution pattern: US Nationwide Distribution in the states of California.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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