Chloraprep One-Step Applicator Recalled for Loose Endcap Releasing Glass Shards
CareFusion 213, LLC is recalling Chloraprep One-Step applicators because the endcap may fall off during activation, releasing glass shards into the solution.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
CareFusion 213, LLC is recalling 707,050 units of Chloraprep One-Step (Chlorhexidine Gluconate and Isopropyl Alcohol) sterile solution applicators. The product is a 26 mL applicator containing 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol, manufactured in El Paso, TX, and distributed nationwide within the United States.
The recall was initiated due to an increase in complaints identifying that the endcap of the applicator may be loose or fall off upon activation. This defect can result in the release of glass shards containing the solution. The affected lots include 0108186 (Exp. 4/30/2023) and a series of lots expiring 11/30/2023, including 0327867, 0327868, 0328213, 0338656, 0339071, 0328947, 0328949, 0329475, 0329477, 0330457, 0330955, 0330606, 0333826, 0333852, 0333855, 0334119, 0335787, 0335792, 0335029, 0336506, 0336972, 0336051, 0337245, 0337025, 0338653, 0338542, 0338852, 0339892, and 0339457.
Consumers and healthcare providers should stop using the affected products and contact CareFusion 213, LLC for further instructions or a return. The FDA has classified this recall as Class I, indicating a reasonable probability that the use of or exposure to the violative product will cause serious adverse health consequences or death.
The recalled product
- Product
- CHLORAPREP ONE-STEP (CHLORHEXIDINE GLUCONATE AND ISOPROPYL ALCOHOL)
- Brand
- CHLORAPREP ONE-STEP
- Manufacturer
- CareFusion 213, LLC
- Category
- Drug — Topical Antiseptic
- Hazard
- Affected units
- 707,050
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 (20)
- Lot #: 0108186
- Exp. 4/30/2023
- 0327867
- 0327868
- 0328213
- 0338656
- 0339071
- 0328947
- 0328949
- 0329475
- 0329477
- 0330457
- 0330955
- 0330606 0333826
- 0333852
- 0333855
- 0334119
- 0335787
- 0335792
- 0335029
Distribution
Distributed nationwide across the United States.
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