CareFusion 213, LLC recalls BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol), 60 x 1 mL

What was recalled

The U.S. Food and Drug Administration recently issued a recall notice concerning a specific batch of medical supplies manufactured by CareFusion 213, LLC. This company is a subsidiary of the well-known healthcare giant Beckton, Dickson and Co., often recognized by its BD brand name. The product at the center of this recall is the BD ChloraPrep Clear applicator. These are single-use, sterile swabs designed for skin preparation before procedures like injections or surgeries. They contain a solution of 2% chlorhexidine gluconate (CHG) and 70% isopropyl alcohol, which are standard antiseptic ingredients used to kill bacteria on the skin. The specific product configuration affected by this recall comes in cartons containing 60 individual applicators, with each applicator holding exactly 1 milliliter (0.03 fluid ounces) of the solution.

The scope of this recall is quite broad, covering a wide array of lot numbers that were distributed across the entire United States. The affected items are identified by National Drug Code (NDC) number 54365-400-31. Because these medical supplies are used in hospitals, clinics, and doctor’s offices nationwide, understanding exactly which lots are involved is critical for healthcare providers and patients alike. The recall was officially announced on July 9, 2026, but the products themselves have expiration dates ranging from February 2027 all the way through April 2029. This means that many of these items were likely still in stock or in use at the time of the announcement.

To help you identify if you are holding a recalled item, it is important to look closely at the packaging for specific lot numbers. The recall affects numerous lots, including 4062535, 4065201, and 4066446, among many others with later expiration dates such as 5124984, 5305661, and 6111107. CareFusion 213, LLC is based in El Paso, Texas, which is listed as the state of origin for this distribution pattern. While the company has not stated a specific remedy or refund process in the initial recall facts, healthcare facilities need to verify their inventory against these lot numbers immediately to ensure patient safety.

This Class II recall indicates that while the use of the product may be temporarily hazardous, it is not likely to cause serious adverse health consequences or death. However, the lack of sterility assurance is a significant concern in medical settings where infection prevention is paramount. By identifying the exact brand, model, and lot numbers now, you can take the necessary steps to remove these items from circulation and replace them with safe, sterile alternatives.

The hazard, explained

When you look at the details of this FDA Class II recall for BD ChloraPrep Clear applicators, the core issue is surprisingly simple but potentially serious: the packaging may not be properly sealed. Specifically, the recall notice indicates that affected units might have an "open or incomplete seal" on the applicator packaging. To understand why this matters, we first need to look at what these swabs are designed to do and how they are made.

BD ChloraPrep Clear is a sterile antiseptic solution containing 2% chlorhexidine gluconate (CHG) and 70% isopropyl alcohol. It is widely used in medical settings to clean the skin before injections, surgeries, or other invasive procedures. The word "sterile" is not just a marketing term here; it is a critical safety requirement. These applicators are manufactured and packaged under strict conditions to ensure that no bacteria, viruses, or fungi are present on the swab tip or inside the liquid when you open the package. The packaging itself acts as a barrier, keeping the outside world out until the moment of use.

The hazard arises when that physical barrier fails. If the seal on the individual applicator pouch is open, torn, or incomplete, the sterile interior is exposed to the environment. In a hospital room, clinic, or even a home care setting, the air and surfaces are teeming with microorganisms. Once the seal is broken before you intend it to be, bacteria from the air, your hands, or nearby surfaces can settle on the swab tip or contaminate the solution inside. Because you cannot see microscopic contamination, a swab that looks perfectly fine on the outside may actually be carrying harmful pathogens.

Why is this dangerous? The primary purpose of using this product is to kill germs on the skin to prevent infection. If the swab itself is contaminated because its seal failed, you are effectively introducing bacteria directly into a wound or injection site instead of cleaning it away. This is particularly risky for procedures that break the skin barrier, such as surgery, catheter insertion, or IV placement. For patients with weakened immune systems, the elderly, or those with chronic conditions, an infection caused by a contaminated swab can lead to serious complications, including bloodstream infections (sepsis) or localized tissue infections.

It is important to note that this is a "Class II" recall, which the FDA uses for situations where use of a violative product may cause temporary health problems or pose only a slight threat of serious disease. This classification suggests that while the risk is real and must be taken seriously, it does not necessarily imply that every single contaminated unit will result in harm. However, because sterility cannot be guaranteed without inspecting each individual package under magnification, the manufacturer has issued a recall to remove potentially compromised units from circulation. The mechanism of injury is indirect: the product fails to provide the sterile environment it promises, thereby turning a safety tool into a potential vector for infection.

In summary, the physical failure here is a packaging defect—an open or incomplete seal—that compromises the sterility of the antiseptic solution. This transforms a tool meant to prevent infection into one that might inadvertently introduce bacteria into vulnerable tissues, making it essential to verify whether you possess any of the affected lots and to follow the proper disposal or return instructions.

Who is most at risk

It is important to clarify right away that this recall does not involve a product found in your home medicine cabinet or on your kitchen counter. BD ChloraPrep Clear is a specialized medical device classified as a sterile solution, distributed nationwide through professional healthcare channels rather than retail stores. Consequently, the general public, including children and families who might typically worry about household safety hazards, are not at risk of accidental exposure or ingestion. The primary group affected by this recall consists of healthcare professionals—including nurses, surgeons, anesthesiologists, and phlebotomists—and patients currently receiving care in hospitals, surgical centers, clinics, and doctor’s offices where these specific applicators are stocked and used.

The individuals most vulnerable to the consequences of this recall are those undergoing invasive medical procedures. BD ChloraPrep is specifically designed to prepare the skin before needle sticks, surgical incisions, or the insertion of catheters and other devices. The hazard here is a lack of assurance of sterility due to potential open or incomplete seals on the packaging. For a healthy individual getting a routine vaccination, the risk might be minimal. However, for patients who are immunocompromised, elderly, or recovering from major surgery, maintaining a sterile field is critical to preventing serious infections. If the applicator’s seal was compromised during manufacturing, bacteria or other contaminants could have entered the package. Using this product on broken skin or near an open surgical site introduces a direct pathway for infection, which can lead to severe complications such as sepsis, localized abscesses, or prolonged recovery times.

Furthermore, healthcare providers themselves are also at risk, albeit in a different capacity. While the primary danger is to the patient receiving the treatment, medical staff handling these defective units may also be exposed to contaminated materials if they are unaware of the defect. This is particularly relevant for the numerous lots identified in the recall, which have expiration dates ranging from February 2027 through April 2029. Because these products are still within their usable shelf life, they may still be sitting on shelves or in supply rooms across the United States. The risk is not just about who uses the product, but who comes into contact with it during preparation and administration. Therefore, any hospital or clinic in Texas or elsewhere in the U.S. that stocks CareFusion 213, LLC products under the BD brand needs to be vigilant. If you are a patient scheduled for a procedure involving skin prep, knowing that this specific product is being recalled allows you to ask your care team if they have switched to an alternative sterile solution, ensuring your safety during a time when your body’s defenses might already be lowered.

How to tell if you have the recalled item

If you are a healthcare provider, pharmacy manager, or someone who handles medical supplies for home care, verifying whether your inventory contains the affected BD ChloraPrep Clear applicators requires a careful, methodical check. Because this recall involves Class II products distributed nationwide, simply knowing the brand name is not enough to guarantee safety. You must cross-reference multiple specific identifiers on the packaging and the individual applicator boxes to ensure you are not holding a unit from one of the affected lots.

First, confirm that you have the correct product model. The recall specifically targets BD ChloraPrep Clear, which contains 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol. It is crucial to distinguish this from other variants, such as the standard orange-tipped BD ChloraPrep or other non-clear formulations. The recalled items are packaged in cartons containing 60 applicators, with each individual applicator holding 1 mL (0.03 fl oz) of solution. If your cartons contain a different quantity or volume, they are not part of this specific recall notice.

The most critical step is checking the National Drug Code (NDC) and the Lot Number. The affected product carries the NDC 54365-400-31. If you do not see this exact code, the product is likely not part of this recall. Next, look for the Lot Number printed on the carton. The FDA has identified a wide range of specific lots as affected. You must check your inventory against the following list of lot numbers:

• Lots with an expiration date of 2/28/2027: 4062535, 4065201, 4066446
• Lots with an expiration date of 5/31/2027: 4141090
• Lots with an expiration date of 6/30/2027: 4180288, 4197695, 4197697, 4180291
• Lots with an expiration date of 7/31/2027: 4219454, 4221945, 4221966, 4222853, 4224361
• Lots with an expiration date of 8/31/2027: 4228482, 4248656, 4249026, 4248961, 4249818, 4250729
• Lots with an expiration date of 4/30/2028: 5124984, 5127231, 5129058, 5126398, 5129488
• Lots with an expiration date of 5/31/2028: 5130576, 5142947, 5147432, 5154673, 5154671, 5156442, 5157968, 5158031, 5150160, 5155824
• Lots with an expiration date of 6/30/2028: 5176326, 5181676, 5181074, 5182660, 5188102, 5188103
• Lots with an expiration date of 7/31/2028: 5195818, 5199118, 5209474, 5210853, 5211985, 5211907, 5211212
• Lots with an expiration date of 8/31/2028: 5226576, 5227151, 5230531, 5241733, 5242057, 5243430, 5246952, 5248375, 5248189
• Lots with an expiration date of 9/30/2028: 5254509, 5274692, 5276968, 5279226, 5280240
• Lots with an expiration date of 10/31/2028: 5305661, 5307185, 5309623, 5310701
• Lots with an expiration date of 12/31/2028: 5346128, 5350797
• Lots with an expiration date of 1/31/2029: 6031034, 6031234, 6037918
• Lots with an expiration date of 2/28/2029: 6051588, 6054213, 6062168, 6063361
• Lots with an expiration date of 3/31/2029: 6069891
• Lots with an expiration date of 4/30/2029: 6111107

If your inventory matches the NDC and any of the lot numbers listed above, you are holding recalled units. The manufacturer, CareFusion 213, LLC (a subsidiary of Beckton, Dickson and Co.), is based in El Paso, TX, though the product was distributed nationwide across the United States. Because the hazard involves a potential lack of sterility due to open or incomplete seals on the applicator packaging, visual inspection of the individual applicator tips for damage is also wise, but the lot number is your primary confirmation tool. Do not rely on expiration dates alone, as the recall spans multiple years from 2027 through 2029.

What to do — step by step

If you or your healthcare facility are currently in possession of the recalled BD ChloraPrep Clear applicators, the most critical immediate action is to stop using them right away. Because the FDA has identified a "Lack of Assurance of Sterility" in this specific batch, continuing to use these products poses a significant risk. The core issue is that the packaging may have an open or incomplete seal. In medical contexts, sterility is not just a preference; it is a requirement for preventing infections during procedures such as surgery, injection, or wound care. If the seal is compromised, bacteria and other microorganisms from the environment could have entered the applicator tip or the solution itself. Using this product on skin that is about to be punctured or incised could introduce those pathogens directly into the body, potentially leading to serious local or systemic infections. Therefore, even if the package looks intact to the naked eye, you should treat any kit from the affected lots as unsafe until proven otherwise.

The next step involves carefully identifying exactly which items you have in your inventory. You must check the lot numbers printed on the cartons against the specific list provided by CareFusion 213, LLC. The recall affects BD ChloraPrep Clear (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) with NDC 54365-400-31. Please verify your stock against the following lot numbers: 4062535, 4065201, 4066446, 4141090, 4180288, 4197695, 4197697, 4180291, 4219454, 4221945, 4221966, 4222853, 4224361, 4228482, 4248656, 4249026, 4248961, 4249818, 4250729, 5124984, 5127231, 5129058, 5126398, 5129488, 5130576, 5142947, 5147432, 5154673, 5154671, 5156442, 5157968, 5158031, 5150160, 5155824, 5176326, 5181676, 5181074, 5182660, 5188102, 5188103, 5195818, 5199118, 5209474, 5210853, 5211985, 5211907, 5211212, 5226576, 5227151, 5230531, 5241733, 5242057, 5243430, 5246952, 5248375, 5248189, 5254509, 5274692, 5276968, 5279226, 5280240, 5305661, 5307185, 5309623, 5310701, 5346128, 5350797, 6031034, 6031234, 6037918, 6051588, 6054213, 6062168, 6063361, 6069891, and 6111107. If your lot number matches any of these, do not attempt to re-seal or inspect the individual applicators for sterility yourself; this is a manufacturing defect that cannot be fixed by the end user.

Regarding the remedy, please note that the official recall announcement does not currently specify whether CareFusion 213, LLC is offering refunds, replacements, or repairs. In Class II recalls, manufacturers often arrange for the return of goods to their facility or provide credit notes on future orders, but this information is not explicitly detailed in the current FDA data. Because the remedy is not stated, you should contact CareFusion 213, LLC directly at their address in El Paso, TX, or through their official customer service channels to inquire about their specific return procedures. Do not discard these items in regular trash, as they may require special handling as potentially contaminated medical waste depending on your facility's protocols. Secure the boxes in a safe location away from active clinical areas until you have received further instructions from the manufacturer.

For healthcare providers, it is also vital to communicate this recall to all relevant staff members immediately. Ensure that nurses, surgeons, and technicians are aware that these specific lots are out of service. Replace the recalled stock with verified sterile alternatives from a different lot number or manufacturer before proceeding with any scheduled procedures. Ignoring this step could compromise patient safety and violate standard infection control practices. If you have already used items from these lots on a patient, monitor that patient closely for any signs of infection at the site of application, such as redness, swelling, warmth, or discharge, and report any adverse events to the FDA’s MedWatch program.

Your refund, repair, or replacement options

When you encounter a product recall, especially one involving medical supplies like the BD ChloraPrep Clear applicators pulled by CareFusion 213, LLC, your immediate concern is often what to do with the item and how to make things right. It is completely natural to feel a mix of frustration and uncertainty in this situation. You have likely purchased these items with the expectation of safety and reliability, so finding out they are part of an official recall can be unsettling. However, the process for resolving this issue is designed to protect you while minimizing inconvenience.

In reviewing the official details provided by the Food and Drug Administration (FDA) regarding this specific Class II recall, it is important to address the remedy directly. The recall facts state that a remedy is "not stated." While this phrase might initially sound vague or unhelpful, in the context of regulatory communications, it typically means that the manufacturer has not yet published a single, universal public instruction for every consumer in this specific summary document. However, this does not mean you are left without options or recourse. In standard practice for Class II recalls involving sterile medical solutions, the "remedy" is almost always centered around returning the product to the point of sale or contacting the manufacturer for a credit, replacement, or refund. The lack of a specific public remedy statement in this brief does not negate your right to seek resolution; it simply means you must look for the contact information provided on the original packaging or through CareFusion’s direct customer service channels.

To determine your specific options, you should first locate the lot numbers and expiration dates printed on your package. As listed in the recall notice, this affects a wide range of lots from 4062535 to 6111107, with expiration dates spanning from February 2027 through April 2029. If your product matches these details, you should not use it. Instead, contact the retailer where you bought the item, such as a hospital supply vendor or online medical store. Most reputable distributors have established protocols for handling recalled sterile goods. They will likely ask you to return the unused applicators for destruction and issue a refund or credit to your account. If you purchased directly from CareFusion or its subsidiary, Beckton, Dickson and Co., they may offer a replacement with a verified sterile batch or a full reimbursement.

It is crucial not to attempt to "repair" the packaging yourself. The hazard here is a lack of assurance of sterility due to an open or incomplete seal. No amount of tape or resealing can restore the sterile integrity of a medical applicator. Therefore, your only viable options are financial restitution (refund) or product replacement with a non-recalled unit. Keep your proof of purchase and the specific lot numbers handy when you contact the seller. This documentation will streamline the process and ensure you receive whatever compensation is available according to their current policy.

If you cannot find the original receipt, do not panic. Many medical supply companies can track orders by credit card number or patient name if the sale was recent. If you are a healthcare facility, your procurement department should handle the return process in bulk. For individual consumers, persistence is key. Call the customer service number on the box or the company’s main line. Explain that you have a recalled item due to sterility concerns. Even if a specific remedy isn't listed in this brief summary, companies are legally and ethically obligated to address safety recalls. They will guide you through their specific return and refund procedure.

Remember, your health is the priority. By securing a refund or replacement, you ensure that you are using safe, sterile products for any medical procedures. Do not hesitate to ask questions during the process. If the seller is unresponsive, consider reaching out to the FDA’s safety reporting portal for further assistance, though direct resolution with the manufacturer or retailer is usually the fastest path to getting your money back or a safe product in hand.

What can happen if you ignore it

It is completely understandable why you might hesitate to stop using a product that appears perfectly fine on the surface. The BD ChloraPrep Clear applicators involved in this recall are designed for skin preparation, and their primary job is to clean the area before a medical procedure. Because the packaging looks intact to the naked eye and the solution inside may still look clear and active, it is easy to assume that the product is safe to use. However, ignoring this FDA Class II recall carries specific, serious risks that go beyond simply wasting a few dollars or replacing an item later.

The core issue here is not that the chemical composition of the chlorhexidine gluconate or isopropyl alcohol has changed; those ingredients are still effective at killing bacteria on the skin. The hazard lies in the assurance of sterility. When the FDA notes a lack of assurance due to an open or incomplete seal, it means that microscopic pathways may exist through which contaminants can enter the package. Even if you cannot see a hole or tear, the seal may have failed during manufacturing or shipping. This means the applicator tip is no longer guaranteed to be free from bacteria, fungi, or other pathogens.

If you use this product on yourself or a patient, you are essentially introducing potential contaminants directly to a site that is about to be punctured or cut. In medical contexts, skin preparation is a critical barrier against infection. When that barrier is compromised by a non-sterile applicator, the risk of surgical site infections (SSIs) increases significantly. These are not minor inconveniences; they are serious complications that can lead to prolonged hospital stays, additional surgeries, antibiotic resistance, and in severe cases, systemic infections like sepsis. The consequence of ignoring the recall is that you lose the protective advantage the product was designed to provide.

Furthermore, there is a practical layer to this risk. Because the remedy for this specific recall has not been publicly stated by CareFusion or the FDA as of this writing, you cannot simply mail the item back for a standard refund without further instructions. Continuing to use these lots from El Paso, Texas, means you are holding inventory that may need to be quarantined or destroyed under strict protocols once official guidance is released. If medical facilities or individuals continue to administer procedures using these potentially compromised applicators and an infection occurs, it complicates the clinical response and creates unnecessary liability.

The most significant danger, however, is the false sense of security. An open seal might allow environmental microbes to colonize the tip over time, even if the alcohol evaporates slightly. Using a non-sterile swab on broken skin or near an incision site is akin to wiping a wound with a dirty cloth. The chemicals in ChloraPrep are meant to disinfect; they are not designed to sterilize a contaminated applicator tip after it has already been exposed to the environment through a faulty seal. Therefore, ignoring this recall turns a safety tool into a potential vector for infection.

Staying safe: broader tips

When dealing with medical supplies like antiseptic swabs, the primary goal is maintaining a sterile environment to prevent infection. While this specific recall highlights a potential packaging defect, you can take several general steps to ensure your own safety when using any sterile medical product. First, always inspect the packaging before opening. Look for tears, punctures, or any signs that the seal has been broken. If the package appears compromised in any way, do not use the item. An open or incomplete seal means the sterility of the applicator can no longer be guaranteed, which could introduce bacteria into a wound or injection site.

Proper storage is another critical factor in maintaining product integrity. Store medical supplies in a cool, dry place away from direct sunlight and extreme temperatures. Heat and humidity can degrade packaging materials over time, potentially compromising the seal even if it looks intact. Keep these items out of reach of children and pets to prevent accidental damage or misuse. Always check the expiration date before use; using expired products can reduce their effectiveness and increase the risk of adverse reactions.

It is also important to stay informed about product recalls. Sign up for email alerts from the FDA and other relevant safety organizations so you receive timely updates on recalled items. Regularly check the FDA’s website for new recall notices, especially if you use medical products frequently. This proactive approach can help you identify and avoid potentially hazardous items before they cause harm.

Finally, practice good hygiene when handling any medical supplies. Wash your hands thoroughly with soap and water before touching sterile packages or applying antiseptic solutions. Use clean gloves if necessary, and avoid contaminating the applicator tip by touching it to non-sterile surfaces. If you have any doubts about the safety or sterility of a product, err on the side of caution and contact the manufacturer or your healthcare provider for guidance. By staying vigilant and informed, you can help ensure that your medical supplies remain safe and effective for their intended use.

• Inspect packaging for tears, punctures, or broken seals before each use.
• Store medical supplies in a cool, dry place away from direct sunlight.
• Check expiration dates regularly and discard any expired products.
• Sign up for FDA recall alerts to stay informed about potential hazards.
• Maintain proper hygiene by washing hands and using clean gloves when handling sterile items.

By following these general safety tips, you can help minimize risks associated with medical supplies and ensure that you are using products that are safe and effective for your healthcare needs. Remember, when in doubt, consult with a healthcare professional or the product manufacturer for specific advice tailored to your situation.