# FDA recall Z-2483-2018

> **Cardinal Health 200, LLC** · Class II · device recall initiated 2018-02-20.

## 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.

## 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

- **Recall number:** Z-2483-2018
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class II
- **Product type:** device
- **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

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2483-2018

## Citation

> AI Analytics. FDA recall Z-2483-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2483-2018. Source: US FDA. Licensed CC0.

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