Carefusion Recalls ChloraPrep Applicators Due to Incomplete Seals
Carefusion is recalling 67,775 ChloraPrep with Tint applicators because some units had incomplete seals, potentially compromising sterility.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving sterile medical products where sterility assurance is compromised.
Plain-English summary
Carefusion 213, LLC is recalling 67,775 units of ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicators. The product is a sterile, external-use preoperative skin preparation. The recall was initiated after a customer complaint reported that some units had incomplete seals on the individual unit packaging.
The incomplete seals raise concerns about the assurance of sterility for the affected applicators. The product is identified by product code 260415 and Lot number 48225. The recall is classified as Class II by the FDA.
The affected units were distributed nationwide. Consumers and healthcare facilities should stop using the recalled product and contact Carefusion for further instructions or a return.
The recalled product
- Product
- ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA
- Manufacturer
- Carefusion 213, Llc
- Category
- Medical Device — Surgical Prep
- Hazard
- Affected units
- 67,775
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)
- Product code 260415
- Lot#: 48225
Distribution
Distributed nationwide across the United States.
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Similar recalls
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