Cardinal Health Pre-Op Decolonization Kit Recall for Missing Nasal Swabs
Cardinal Health is recalling pre-operative decolonization kits that contain only one nasal swab instead of the four required for proper treatment.
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 hazard is a minor labeling/packaging error (missing components) with no reported injuries or illnesses, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Cardinal Health 200, LLC is recalling 9,150 units of the KIT, PRE OP DRAH (Model ORPDH5994A). This pre-operative kit is used to decolonize intranasal S. aureus. The recall is due to a packaging error where the kits contain only one nasal swab instead of the four required for proper treatment.
The affected lots are 558357, 561502, 566549, 571467, and 574058. Expiration dates vary by kit components. The product was distributed nationwide in the US, including North Carolina.
Healthcare providers and consumers should stop using the affected kits and contact Cardinal Health for a replacement or refund.
The recalled product
- Product
- KIT, PRE OP DRAH - Product Usage: Preoperative kit used to decolonize intranasal S. aureus.
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 9,150
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)
- Model: ORPDH5994A Lot numbers: 558357
- 561502
- 566549
- 571467
- 574058. Expiration dates: Varies by kit components.
Distribution
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