Cardinal Health Recalls Presource PBDS Kits Due to Leaking Gatorade Pouches
Cardinal Health is recalling Presource PBDS kits because a defect in the Gatorade pouch seal caused the pouch to leak within the kit.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is a leaking pouch, which is a functional defect but does not involve high-risk pathogens or reported injuries, fitting the criteria for a moderate severity recall.
Plain-English summary
Cardinal Health 200, LLC is recalling 8,928 units of the Presource PBDS, Kit, No Spiro. The kit is provided to patients pre-surgery as part of the Enhanced Recovery After Surgery protocol and includes an exerciser volumetric 5000 ML device, cloth, skin prep 2% CHG, chlorhexidine gluconate antiseptic cloths, and Gatorade pouches.
The recall was initiated because a defect in the seal of the Gatorade pouch contained in the kits caused the pouch to leak within a limited portion of the kit. The affected product codes are SP4692448A (Lot Numbers 820351, 821944, 822521, 828183) and SP4692448B (Lot Number 851604).
The affected kits were distributed nationwide in the state of California. The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled product.
The recalled product
- 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
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- Affected units
- 8,928
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Product Code SP4692448A (Lot Numbers 820351
- 821944
- 822521
- 828183). Product Code SP4692448B (Lot Number 851604).
Distribution
Part of a larger recall action
This product is one of 4 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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