CareFusion Recalls ChloraPrep Applicators Due to Sterility Concerns
CareFusion is recalling 23,000 ChloraPrep applicators because immediate product pouches may not be properly sealed, potentially compromising sterility.
What this means for you
Illness, injury, or structural failure has been reported. 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, which corresponds to a Severe rating under the rubric, particularly given the risk of infection from non-sterile medical devices.
Plain-English summary
CareFusion 213, LLC is recalling 23,000 units of ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL applicators. The specific lot number is 71132, with an expiration date of 02/2017. The product is distributed nationwide in the U.S.
The recall was initiated due to a lack of assurance of sterility. Specifically, the immediate product pouches may not be properly sealed, which could compromise the sterile status of the applicators.
Healthcare providers and facilities should stop using the affected product and contact CareFusion for further instructions. Consumers should not use the product if they have it in their possession.
The recalled product
- Product
- ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.
- Manufacturer
- CareFusion 213, LLC
- Category
- Medical Device — Surgical Prep
- Affected units
- 23,000
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 #: 71132
- Expiry: 02/2017
Distribution
Distributed nationwide across the United States.
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