Convenience Kit Correction: Medline Issues Correction for Convenience Kits Containing BD ChloraPrep Applicators

The FDA has since determined that this device may cause temporary or reversible health problems, or—though unlikely—serious health problems. This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The affected products have been updated.

Recommendations for what to do with the devices below have not changed.Affected ProductThe FDA is aware that Medline has issued a letter to affected customers recommending certain convenience kits be corrected by removing BD ChloraPrep applicators affected by the BD ChloraPrep Recall. Affected devices:Medline Convenience KitsFull list of Affected ProductsWhat to DoRemove affected BD ChloraPrep applicators. Apply over-labels to all affected kits on hand stating that the affected components must be removed and discarded prior to use.On June 12 and July 20, Medline sent all affected customers letters recommending the following actions:Immediately check your stock for any affected product and quarantine.

Other components within the convenience kits may still be used. Apply provided over-labels to any affected kits on hand stating that the affected component must be removed and discarded prior to use. If you are a distributor or have resold or transferred this product, notify them of this recall communication.

Continue to check this web page for updates. The FDA continues to review information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.Reason for CorrectionMedline stated that Becton, Dickinson and Company is conducting a Drug Recall of specific lots of the BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators due to:Potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area or The affected product may exhibit an open or incomplete seal on the packaging of the applicator If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences may include no injury, localized infection, or, less commonly, more serious infection requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization.

In rare cases, particularly in critically ill or immunocompromised patients, severe infection could become life-threatening. Patients who may have been exposed should be monitored according to clinical judgment for signs or symptoms of infection, and any suspected infection should be evaluated and treated promptly. Patients who may have been exposed without complications do not require follow up.

As of August 3, Medline has reported no serious injuries or deaths associated with this issue.Device UseConvenience kits contain various surgical instruments, dressings and/or other materials, and pharmaceutical components that are intended to be used during various surgical procedures. Contact InformationCustomers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Medline at recalls@medline.com or 866-359-1704.Additional FDA Resources FDA Enforcement ReportEvent ID 99334Event ID 99561CDRH Medical Device Recalls Database Event ID 99334Event ID 99561Related Upstream RecallsFDA Enforcement Report [Event ID 99114]FDA Enforcement Report [Event ID 99377]BD Issues Nationwide Recall for Specific Lots of ChloraPrep™ Clear Single Sterile 1 mL and FREPP™ Clear 1.5 mL Applicators Due to Microbial Contamination | FDA [06/08/2026] Unique Device Identifier (UDI)The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use.

The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.How do I recognize a UDI on a label?AccessGUDID database - Identify Your Medical Device Benefits of a UDI SystemHow do I report a problem?Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.Timeline of Communication UpdatesDateActions09/02/2026The FDA updated this communication to add additional lot numbers to the affected product list. The FDA updated this communication to update the affected products section and inform the public that this issue has been classified as a Class II Recall. 08/12/2026The FDA updated this communication to add additional lot numbers to the affected product list.07/09/2026The FDA issued an Early Alert communication to notify the public of a potentially high-risk device issue.