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ChloraPrep Clear 1 mL applicator skin preparation product Recall Due to Poten...

# Major Recall Alert: ChloraPrep Clear 1 mL Applicator Skin Preparation Product Recalled Due to Potential Fungal Contamination

BD (Becton, Dickinson and Company) has issued an urgent voluntary recall of its **ChloraPrep™ Clear 1 mL applicators** due to the potential for fungal contamination under certain environmental conditions. This recall has been initiated due to the risk of contamination by **Aspergillus penicillioides**, a fungus capable of causing severe infections. The impacted lot has been distributed globally, starting in September 2023. Here’s everything you need to know about this important recall.

## Why This Recall is Important

The **ChloraPrep Clear 1 mL applicator** is used as a skin preparation product prior to invasive surgical or medical procedures. The primary concern of the recall is that contamination with **Aspergillus penicillioides** may lead to direct fungal exposure during patient preparation. This risk is serious, as exposure to this fungus can result in:

- **Systemic infections**
- **Sepsis**
- Infections necessitating **additional surgical and medical treatment**
- **Intravascular catheter infections**, which can cause significant health complications and require catheter removal
- Prolonged **antifungal drug treatments**

The consequences of contamination are life-threatening, especially for patients with compromised immune systems. While there have been no reported adverse events or complaints associated with the affected lot, BD is proactively recalling the product to ensure patient safety.

## Details of the Recall

Below are the key details regarding the recall:

- **Product Name**: ChloraPrep™ Clear 1 mL Applicators
- **Manufacturer**: BD (Becton, Dickinson and Company)
- **Affected Lot Number**: 3200240
- **Distribution Start Date**: September 2023
- **Potential Risk**: Growth and transfer of **Aspergillus penicillioides**, leading to fungal exposure during use
- **Usage**: Skin preparation prior to surgical or invasive medical procedures
- **Packaging Details**: Single-use applicator (1 per pouch), 60 applicators per inner carton

This recall has been carried out to the **Distributor, Hospital, and User levels**. The FDA has also been notified, and BD is working actively with health care facilities, distributors, and customers to remove the affected product from circulation.

Find more official details on the FDA press release here: [FDA's Official Recall Page](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bd-announces-voluntary-worldwide-recall-one-lot-chlorapreptm-clear-1-ml-applicators-due-fungal).

## What You Should Do

If your facility uses ChloraPrep Clear 1 mL applicators, it is critical to take action immediately.

1. **Check Your Inventory**: Look for **lot number 3200240** on product packages, shelf boxes, or shipper boxes.
2. **Discontinue Use**: Stop using the affected lot immediately.
3. **Dispose or Quarantine Affected Units**: Destroy the affected products as per your facility’s guidelines. If immediate disposal isn’t possible, quarantine the product to prevent use.
4. **Contact BD for Assistance**: For additional questions, you can contact **BD’s Complaint Center** at 1-844-823-5433 (Monday to Friday, 9 AM–6 PM ET) or **email**: productcomplaints@bd.com.

Adverse events or reactions should also be reported to the **FDA MedWatch Adverse Event Reporting Program**:

- **Online**: [FDA MedWatch Reporting](https://www.accessdata.fda.gov/scripts/medwatch/)
- **Phone**: 1-800-FDA-1088
- **Mail**: Use the FDA’s postage-paid FDA Form 3500

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This proactive step helps safeguard public health by ensuring swift action whenever issues like these arise.

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