FDA Early Alert for Product Safety Recall

FDA Warns of Convenience Kits Containing Recalled Cardinal Health Alcohol Pads

The FDA has issued an Early Alert regarding several medical convenience kits distributed by Windstone Medical Packaging, Inc. that contain alcohol prep pads previously recalled by Cardinal Health due to microbial contamination.

The affected convenience kits contain Cardinal Health Webcol™ Large Alcohol Prep Pads that were included in a nationwide recall after testing identified contamination with Paenibacillus phoenicis, a microorganism capable of causing serious infections in vulnerable patient populations.

Affected Convenience Kits

The affected products include:

DSAEK Pack – RX (AMS12394B)

Thyroid FNA Pack – RX (AMS17729)

Preop Kit – NS (AMS18227)

Dr. Lewin Pack (AMS7200D)

The affected component within the kits is the Cardinal Health Webcol Large Alcohol Prep Pad, Part Number 5110, Lot Number 25K006462.

The convenience kits are used during a variety of surgical and procedural applications and may contain surgical instruments, dressings, pharmaceutical products, and other procedural supplies.

Corrective Action Instead of Full Kit Recall

Rather than recalling the entire convenience kits, Windstone Medical Packaging and Aligned Medical Solutions have implemented a field correction strategy.

Healthcare facilities are instructed to identify affected inventory, apply an over-label provided by the manufacturer, and remove and discard the affected Cardinal Health alcohol prep pad when the kit is opened for use.

Then, dispose of the recalled pad in accordance with institutional medical waste procedures and continue to use the remaining kit contents as intended. Replacement products may be requested as needed.

This approach allows healthcare providers to continue using unaffected kit components while removing the potentially contaminated alcohol prep pads from service.

Potential Patient Risks

According to FDA, use of contaminated alcohol prep pads during skin preparation prior to injections, blood draws, or other invasive procedures may increase the risk of infection. Particularly vulnerable populations include critically ill, immunocompromised, neonatal, and pediatric patients.

As of June 4, 2026, Windstone Medical Packaging reported no serious injuries or deaths associated with the affected convenience kits.

Why FDA Issued an Early Alert

FDA’s Early Alert program is intended to notify healthcare providers and the public of potentially high-risk medical device issues before the agency completes its full evaluation.

The agency noted that it continues to review information related to this issue and will provide additional updates as new information becomes available.

MDP Regulatory Intelligence Perspective

This recall illustrates how a quality issue involving a single component can affect finished medical devices long after those products have left the manufacturing facility.

In this case, Windstone Medical Packaging did not manufacture the contaminated alcohol prep pads. However, because the recalled component was incorporated into finished convenience kits, the company was required to initiate a field action to protect patients and notify customers.

Corrective action also demonstrates a risk-based recall strategy. Rather than recalling and destroying entire convenience kits, the company identified the specific affected component and implemented a process that allows healthcare providers to remove and dispose of the recalled alcohol prep pad while continuing to use the remaining kit contents.

For quality and regulatory professionals, the event highlights the importance of component traceability, supplier management, field action procedures, and the ability to rapidly identify where purchased components have been incorporated into finished products.

Links

Read the FDA Early Alert here.

Read the Cardinal Health recall notice here.