Monarch Labs Medical Maggots with the accessory LeFlap dressing (previously known as Creature Comforts II), 250-500 per

FDA device recall Z-2207-2010 · posted 2010-08-11 · Terminated

Recall details

Recalling firm

Monarch Labs, LLC

Reason for recall

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.

Action taken

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" .

Root cause

Other

Status

Terminated

Product code

NQK

Quantity affected

14 vials

Distribution

Nationwide Distribution -- CA, IA, KY, IL, TX, SC & UT.

Date initiated

2009-05-03

Date posted

2010-08-11

Date terminated

2012-12-13

Location

Irvine, CA

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