Cardinal Health 200, LLC: Medical Device Recall in 2018 - (Recall #: Z-2483-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 20, 2018

Date Posted: July 25, 2018

Recall Number: Z-2483-2018

Event ID: 80289

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.

Status: Terminated

Product Quantity: 8,928 kits total

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.

Voluntary or Mandated:

Voluntary: Firm initiated