Monarch Labs, LLC Monarch Labs Medical Maggots with the accessory LeFlap dressing (previously known as Creature Comforts II), 250-500 per vial, Batch #: MM-090406 with CCII-0901. Maggot therapy is intended to debride serious non-healing (chronic) wounds, and the dressing intended to confine the maggots to the wound. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Monarch Labs initiated the field notification regarding their Medical Maggots from Batch MM090406 with the accessory LeFlap dressing due a customer complaint from a physician of a patient developing cellulitis after using maggots from the affected batch.

Recommended Action

Per FDA guidance

The customer recall communication was initiated on May 3, 2009 with Monarch Labs notifying all consignees with a via a faxed Recall Letter with fax-back attachment of the initial compliant they had received and the possible infection that may occur if instructions for use are not followed. All therapists, who used maggots from that batch were instructed to contact the firm immediately if they have experienced any adverse events, such as infection, cellulitis, or any other problem. If not, they were asked to simply return the fax-back attachment , noting "no problem" .