FDA recall Z-2482-2018

Cardinal Health 200, LLC · Class II · device

Product

Presource PBDS, Kit, No Spiro. 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.

Distribution

US Nationwide Distribution in the states of California.

Key facts

Status
Terminated
Initiation date
2018-02-20
Report date
2018-07-25
Termination date
2019-11-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2482-2018