CDRH is issuing this Early Alert to notify the public of a potentially high-risk device issue. The FDA will keep the public informed and update this web page as significant new information becomes available.  

Affected Product

The FDA is aware that Medline has issued a letter to affected customers recommending certain convenience kits be removed from where they are used or sold. Affected devices:

Full list of Affected Products

What to Do

Remove 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, Medline sent all affected customers a letter 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.  

Check this web page for updates. The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available.  

Reason for Alert

Medline 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 a potential breach of sterility in the packaging, due to wrinkles in the paper lidding which may extend to the seal area. 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 June 12, Medline has reported no serious injuries or no deaths associated with this issue.

Device Use

Convenience kits contain various surgical instruments, dressings and/or other materials, and pharmaceutical components that are intended to be used during various surgical procedures.  

Contact Information

Customers 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  

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 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.