Cardinal Health Recalls Presource PBDS Kits Due to Leaking Gatorade Pouches
Cardinal Health is recalling 8,928 Presource PBDS kits because a defect in the Gatorade pouch seal caused the pouch to leak within the kit.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, and the hazard involves a leaking pouch which is a minor defect with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Cardinal Health 200, LLC is recalling 8,928 units of the Presource PBDS, Kit, No Spiro Diabetes. The kit is provided to patients pre-surgery as part of the Enhanced Recovery After Surgery protocol and includes an exerciser volumetric device, skin prep 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 products were distributed nationwide in the state of California.
Consumers should check their kits for the specific product codes and lot numbers listed in the recall notice. If the product matches the recalled items, consumers should contact Cardinal Health 200, LLC for further instructions on how to proceed.
The recalled product
- 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…
- 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 (5)
- Product Code SP4692448A (Lot Numbers 820354
- 821943
- 826374
- 833181). Product Code SP4692448B (Lot Number 849841
- 855450).
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.
See all 4 products in this recall →Related recalls
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