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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Cardinal Health 200, LLC: A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.

Agency Publication Date: July 18, 2018
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Affected Products

Product: Presource PBDS, Kit, Common 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-operati

Product Code SP1692448A (Lot Numbers 820353, 821937, 822523, 826984, 827083, 828090, 830102), Product Code SP1692448B (Lot Number 849805)

Lot Numbers:
SP1692448A
Numbers
SP1692448B
Number
Product: Presource PBDS, Kit, Common. 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 compli

Product Code SPK692448A (Lot Numbers 820352, 821938, 822522, 825665, 826987, 839110), Product Code SP1692448B (Lot Number 841315, 841803).

Lot Numbers:
SPK692448A
Numbers
SP1692448B
Number
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 comp

Product Code SP4692448A (Lot Numbers 820351, 821944, 822521, 828183). Product Code SP4692448B (Lot Number 851604).

Lot Numbers:
SP4692448A
Numbers
SP4692448B
Number
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-opera

Product Code SP4692448A (Lot Numbers 820354, 821943, 826374, 833181). Product Code SP4692448B (Lot Number 849841, 855450).

Lot Numbers:
SP4692448A
Numbers
SP4692448B
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80289
Status: Resolved
Manufacturer: Cardinal Health 200, LLC
Manufactured In: United States
Units Affected: 4 products (8,928 kits total)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.