A routine safety check at Cardinal Health has turned into a major product recall, with the Dublin-based company pulling hundreds of lots of its Webcol™ Large Alcohol Prep Pads over bacterial contamination concerns. The pads, a staple in clinics and hospitals for cleaning skin before injections and minor procedures, are now under a voluntary recall that spans the United States, Puerto Rico and Japan. The company and regulators say vulnerable patients could be at risk, although no illnesses have been reported so far.
In a March 2 recall letter to customers, Cardinal Health said certain Webcol pads were "deemed non-sterile" after a contaminant identified as Paenibacillus phoenicis was detected during a routine sterilization dose audit. The notice instructs customers to review their inventory and immediately pull and quarantine any affected product.
Local reporting from Cleveland.com notes that the recall covers more than 300 lots and that shipments went out across the U.S., Puerto Rico and Japan. Cleveland.com also reports that Cardinal alerted customers via overnight mail to speed up the response.
According to the recall instructions from Cardinal Health, distributors are told to segregate and quarantine impacted lots, arrange returns using the enclosed directions, and fax an acknowledgment form to 614-652-9648 or email [email protected] to coordinate logistics. The company also set up a market-action phone line at 800-292-9332 and says it has notified the U.S. Food and Drug Administration about the recall.
Why the recall matters
The contaminant is not easy to detect, but recall summaries from vendors warn it may pose an infection risk for critically ill, immunocompromised, neonatal and pediatric patients. That makes the affected pads a nonstarter for use in those high-risk settings. So far, Cardinal has not received reports of patients being harmed, according to a notice from Express Scripts.
Hospitals and suppliers react
Distributors and suppliers have been pushing out the notice through their own channels, telling customers to notify anyone who might have received the product and to quarantine stock immediately. For hospitals and clinics that go through prep pads by the case, that can mean a sudden inventory headache.
Vendor bulletins on Medline list the Webcol recall among March supply updates and link out to the manufacturer's detailed instructions, giving materials managers one more item to juggle in an already crowded inbox.
What to do if you or your clinic might be affected
Providers and clinics are being urged to compare the lot numbers on their Webcol Large Alcohol Prep Pads with the affected-lot list in the recall notice and to stop using any matching product immediately. Cardinal's letter includes an attachment with dozens of impacted lot numbers and step-by-step return instructions that vendors such as Performance Health have posted for customers.
Patients who believe they were treated with the recalled pads and who develop symptoms should contact a healthcare provider for evaluation. Any adverse events or quality problems can be reported to the FDA MedWatch program at 1-800-332-1088.
This is a developing story, and more details are likely as companies and regulators update their notices. For additional context and a list of affected lots, see the original reporting from Cleveland.com.
