Cardinal Health Recalls Presource Kit Total Joint Pack Due to Sterility Concerns
Cardinal Health Inc. is recalling 182 Presource Kit Total Joint Packs distributed in Florida because the double-wrapped basin component is not supported by current sterility assurance validation.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a theoretical sterility assurance issue rather than a confirmed contamination or injury event, fitting the criteria for a moderate severity score.
Plain-English summary
Cardinal Health Inc. is recalling 182 Presource Kit Total Joint Packs containing a double-wrapped basin component. The product is used on patients undergoing joint replacement knee or hip surgeries. The recall was initiated because the double wrapping of this custom kit basin set is not supported by the current sterility assurance validation.
The affected products are identified by product code SOP22TJCLK and lot numbers 104405, 122793, and 987948. These packs were distributed to facilities in the US state of Florida.
Healthcare facilities should stop using the affected products and contact Cardinal Health Inc. for further instructions. Patients who have already received treatment with these kits should contact their healthcare provider if they have concerns.
The recalled product
- Product
- Presource Kit Total Joint Pack containing a double-wrapped basin component. Product Usage: This kit is used on patients undergoing joint replacement knee or hip.
- Manufacturer
- Cardinal Health Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 182
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 (3)
- Product code: SOP22TJCLK Lot numbers # 104405
- 122793
- and 987948
Distribution
Distributed in 1 state:
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