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U.S. Department of Health and Human Services

Class 2 Device Recall Medical Maggots with the accessory LeFlap dressing

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 Class 2 Device Recall Medical Maggots with the accessory LeFlap dressingsee related information
Date Initiated by FirmMay 03, 2009
Date PostedAugust 11, 2010
Recall Status1 Terminated 3 on December 13, 2012
Recall NumberZ-2207-2010
Recall Event ID 56031
510(K)NumberK072438 
Product Classification Medical Maggots - Product Code NQK
ProductMonarch 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.
Code Information Batch #: MM-090406 with CCII-0901
Recalling Firm/
Manufacturer		 Monarch Labs, LLC
17875 Sky Park Circle, Ste K
Irvine CA 92614
For Additional Information Contact
949-679-3000
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionThe 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" .
Quantity in Commerce14 vials
DistributionNationwide Distribution -- CA, IA, KY, IL, TX, SC & UT.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = NQK
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