Z-2482-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 25, 2018
- Initiation Date
- February 20, 2018
- Termination Date
- November 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,928 kits total
Product Description
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 Pattern
US Nationwide Distribution in the states of California.
Code Information
Product Code SP4692448A (Lot Numbers 820351, 821944, 822521, 828183). Product Code SP4692448B (Lot Number 851604).