Becton Dickinson Recalls ChloraPrep Applicators Due to Labeling Error
Becton Dickinson is recalling 628,000 ChloraPrep OneStep applicators because the immediate package is incorrectly labeled as Clear instead of Hi Lite Orange.
The agency’s classification
FDA (Drugs): 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 involves a labeling mixup without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Becton Dickinson & Company is recalling 628,000 units of ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol), 3 mL applicators. The recall is due to a labeling error where the immediate package is labeled as "Chloroprep Onestep (Clear)" but the correct label should be "Chloroprep with Tint (Hi Lite Orange)."
The affected product is identified by Lot 7096622 with an expiration date of 3/21/2020. The distribution pattern includes Illinois, Missouri, Pennsylvania, Tennessee, and Virginia.
Consumers and healthcare facilities should stop using the affected product and contact Becton Dickinson & Company for further instructions or a replacement.
The recalled product
- Product
- ChloraPrep OneStep (Clear) (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)), 3 mL applicator, CareFusion, El Paso, TX 79912 --- NDC 054365-400-11
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Surgical Prep
- Hazard
- Affected units
- 628,000
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)
- Lot 7096622
- exp 3/21/2020
Distribution
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