FDA Early Alert Flags Medline Kits Containing Recalled BD ChloraPrep Applicators

The FDA on Thursday issued an early alert about Medline Industries surgical convenience kits that contain BD ChloraPrep skin-preparation applicators from lots covered by a BD recall, citing a potential breach of the applicators' sterile packaging.

According to the agency's early alert, Medline has written to affected customers recommending that the kits be corrected by removing the BD ChloraPrep applicators. The FDA said it issued the communication to notify the public of a potentially high-risk device issue. The American Hospital Association reported the alert the same day.

What Medline said about the applicators

Medline stated that Becton, Dickinson and Company is conducting a drug recall of specific lots of BD ChloraPrep Clear 1 mL and FREPP Clear 1.5 mL applicators. The reasons it gave are a potential breach of sterility in the packaging, because wrinkles in the paper lidding may extend to the seal area, and the possibility that the applicator packaging has an open or incomplete seal.

The FDA notice says that if the sterile barrier is compromised, patients and users may be exposed to microbial contamination. It lists potential consequences ranging from no injury or localized infection to, less commonly, more serious infection requiring treatment or hospitalization, and says that in rare cases, particularly in critically ill or immunocompromised patients, a severe infection could become life-threatening.

Convenience kits bundle surgical instruments, dressings, other materials and pharmaceutical components for use in surgical procedures. Medline's full list of affected kits is linked from the FDA page, which also lists the related FDA enforcement report entries for the upstream BD recall.

Instructions to hospitals

In a June 12 letter, Medline asked customers to:

• Check stock immediately for affected product and quarantine it.
• Apply over-labels supplied by Medline to affected kits on hand, stating that the affected component must be removed and discarded before use.
• Notify any distributor or other party to which the product was resold or transferred.

Medline said the other components in the kits may still be used. AHA News summarized the company's instruction as removing the recalled kits from where they are used or sold, while noting that other kit components may still be used.

The FDA said it is continuing to review information about the issue and will update the public as significant new information becomes available. Customers with questions were directed to Medline at recalls@medline.com or 866-359-1704.