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 AVID Medical has issued a letter to affected customers recommending convenience kits affected by the BD ChloraPrep Applicator Recall be removed from where they are used or sold.

Affected devices:

  • Device Description (Tray Name): IV START KIT NON-STERILE 
  • Model/Item Number: KRIV26-02 
  • Kit Lot Number: 1658437 
  • Unique Device Identifier: 10809160460481

What to Do

Review inventory for convenience kits affected by this issue, quarantine, and destroy the entire kit after completion of response forms. Be aware that these kits were previously identified as part of a recall and may have over-labels instructing users to remove the discard the affected component at point of use.

On August 18, AVID Medical sent all affected customers a letter recommending the following actions:

  • Be aware that the actions required for certain products identified in a prior AVID Medical notification have changed: 
    • Customers are instructed to destroy the entire convenience kit for products identified in this communication due to potential contamination. 
    • The prior AVID Medical notification issued on July 14, 2026, instructed customers to over-label affected convenience kits with a sticker indicating that the affected component should be removed and discarded prior to use. 
    • This updated action applies only to the items listed in this notification and does not affect any other convenience kits included in the July 14, 2026, notification. 
  • Immediately check your stock for convenience kits affected by this issue. Quarantine all affected product.  
  • Destroy affected product upon completion of your response form. 
  • If you are a distributor or have resold or transferred this product to another company or individual, notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers’ quantities on your response form.

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

AVID Medical stated that certain convenience kits containing recalled BD ChloraPrep applicators should be removed from use due to fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides.  

This action applies to products previously identified in an AVID Medical notification sent on July 14. Be advised that the actions required for certain lots in the original notification have changed based on additional recall details received from BD (Becton, Dickinson and Company) regarding their ChloraPrep applicators. Following the initial notification, BD provided additional information regarding its recall of ChloraPrep Clear 1 mL Single Sterile applicators (BD lot 4032183).  

Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death. If the fungus is introduced into a patient’s bloodstream during placement of an intravascular catheter, the catheter would likely need to be removed, requiring an additional procedure. Infection at a surgical site may also necessitate medical and surgical intervention, as well as long term treatment with antifungal medications.

As of August 6, AVID Medical has not reported any serious injuries or 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 AVID Medical at complaints@owens-minor.com.

Additional FDA Resources  

  1. BD ChloraPrep Applicator Recall: FDA Enforcement Report

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.