Cardinal Health Recalls Judkins Packs Due to Incorrect Medication Labels
Cardinal Health is recalling 298 Judkins Packs in Virginia because they may contain incorrect medication label sheets.
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. The hazard involves incorrect labeling of medication components, which is a significant quality issue but does not meet the criteria for Severe (Class II with hospitalization) or Critical (Class I). It is not a cosmetic defect, placing it at Moderate.
Plain-English summary
Cardinal Health 200, LLC is recalling 298 units of the Judkins Pack (Model SANHDJTVCF, Lot 525067). These medical device kits were distributed in the state of Virginia.
The recall was initiated because a specific component, the label sheet (Part Number 19537LBL), was intermittently mixed with an incorrect medication label sheet. This error occurred within the specific Presource kit identified in the recall notice.
Healthcare facilities and consumers who possess these specific units should stop using them and contact Cardinal Health for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- JUDKINS PACK
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Catheter Kits
- Hazard
- Affected units
- 298
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 (2)
- Model SANHDJTVCF
- lot 525067.
Distribution
Distributed in 1 state:
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