The Recall Desk
ModerateFDA (Devices)·Z-1256-2021·Announced 2021-03-24

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.

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 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
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: