Product Recall  from CardinalHealth

This voluntary recall has been initiated by CardinalHealth for the following reasons:

• The WebcolTM Large Alcohol Prep Pads have been deemed non-sterile following the discovery of
  a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
• Cardinal Health is currently notifying customers and will complete appropriate corrective actions
  to recover impacted product.

Note: This recall should be carried out between the customer and CardinalHealth

WebcolTM Large Alcohol Prep Pads

What is the issue?
The WebcolTM Large Alcohol Prep Pads have been deemed non-sterile following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.

What is the risk to health?
The contaminant has a low probability of detection and may pose a potential infection risk to vulnerable groups such as critically ill, immunocompromised, neonatal, and pediatric patients. Cardinal Health has not received any reports of harm or adverse events.

What other actions is Cardinal Health taking?
Cardinal Health is currently notifying customers and will complete appropriate corrective actions to recover impacted product.

Status : Open

Please review the instructions below and submit your response(s) to Performance Health.

Return Instructions

IMPORTANT - Download the CardinalHealth recall PDF here (Webcol Alcohol Prep Pad Recall Notification Letter.pdf) for full details, affected product, and instructions.

Affected Product Performance Health SKU: 081439470

Here is a short reference of the steps in the PDF:

1. REVIEW your inventory for the affected product code. Location of product code and lot are
   shown on the labels below (Attachment 2). If product has been removed from inner carton
   or case, consider this as impacted and follow the instructions below.
2. COMMUNICATE with all personnel that utilize the listed Webcol™M Large Alcohol Prep Pads.
3. SEGREGATE and quarantine all affected product upon review of your inventory. Affected
   product should not be used. Utilize return directions below to return product.
4. DISSEMINATE this notice to all departments, clinics and external campuses that handle the
   affected products.
5. DISTRIBUTORS please notify any customers to whom you may have distributed/forwarded
   affected product to about this medical device recall and share a copy of this notice.
6. RETURN the enclosed acknowledgment form (from the PDF) via fax to 614-652-9648 or email to GMBFieldCorrectiveAction@cardinalhealth.com, whether you have affected product or not.

Additional contact and return information are included within the CardinalHealth PDF.

Where to find your Lot #