CareFusion 213, LLC 2023-09-27 Health serious FDA
Health · FDA · Recall #FDA-D-1168-2023
BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol… Recall
Issued September 27, 2023 · CareFusion 213, LLC
In September 2023, CareFusion 213, LLC recalled the BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1 mL Applicator cannot be substantiated beyond 12-months although labeled with 36-month expiry. Stability studies indicate that the impacted lots, if stored at 30¿C/75% relative humidity continuously beyond 12 months, may exhibit growth of Aspergillus penicillioides.
What you should do
- 1 Stop using BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact CareFusion 213, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- CareFusion 213, LLC
- Category
- Health
- Recall date
- September 27, 2023
- Units affected
- Not reported
- Sold at
- Distributed nationwide to 100 consignees. Please refer to consignee list.
- Recall number
- FDA-D-1168-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- CareFusion 213, LLC has 3 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.