Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported July 25, 2018
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 comp
A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Cardinal Health 200, LLC recalled Presource PBDS, Kit, No Spiro. Kit includes a exerciser volumetric 5000 ML device, two i… - a moderate-severity action.
Presource PBDS, Kit, No Spiro. Kit includes a exerciser volumetric 5000 ML device, two i… was recalled by Cardinal Health 200, LLC in July 25, 2018. Reason: A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portio…. Check the official notice for the remedy. Verify recall #Z-2482-2018 with the FDA Devices before acting.
The recall
Cardinal Health 200, LLC issued this moderate-severity FDA Devices recall-A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portio….
- Moderate
- severity level
- Class II
- classification
- July 25, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2482-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2482-2018) was formally reported on July 25, 2018, with the manufacturer initiating the action on February 20, 2018. It is classified under Moderate severity (Class II), with a current status of Terminated. Cardinal Health 200, LLC is listed as the recalling firm, operating out of Waukegan, IL. Federal records list the affected scope as 8,928 kits total.
The documented reason for this recall is: 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 data in the federal record shows the product reached: US Nationwide Distribution in the states of California.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,422 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
8,928 kits total
Related Recalls
6
0 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2482-2018 |
| Date reported | July 25, 2018 |
| Date initiated | February 20, 2018 |
| Recalling firm | Cardinal Health 200, LLC |
| Firm location | Waukegan, IL |
| Affected scope | 8,928 kits total |
| Distribution | US Nationwide Distribution in the states of California. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2482-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Cardinal Health 200, LLC. Units affected: 8,928 kits total.
Why was this product recalled? ▼
A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 25, 2018. Severity: Moderate. Recall number: Z-2482-2018.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution in the states of California..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2482-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
CPSC Moderate
Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Serious Injury from Fire and Burn Hazards
· 2026-07-02
CPSC Moderate
Winco Fireworks International Recalls Roman Candles 8 Shot Fireworks Due to Risk of Serious Injury from Explosion and B…
· 2026-07-02
CPSC Moderate
Winco Fireworks International Recalls Unity 7 Shot 200 Gram Aerial Cake Fireworks Due to Risk of Serious Injury from Ex…
· 2026-07-02
CPSC Moderate
Daikin Comfort Technologies Manufacturing Recalls Amana Air Conditioners and Heat Pumps Due to Risk of Serious Injury f…
· 2026-06-25
CPSC Moderate
Super Off-Road Solar Power Banks Recalled Due to Overheating; Imported by Spector & Co.
· 2026-06-25
Compare this recall with Rowenta Recalls Cordless Vacuum Cleaners Due to Risk of Ser… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported July 25, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.