Z-2207-2010

Monarch Labs Medical Maggots with the accessory LeFlap dressing (previously known as Creature Comforts II)...

Name: Z-2207-2010 Monarch Labs Medical Maggots with the accessory LeFlap dressing (previously known as Creature Comforts II)...
Creator: Monarch Labs, LLC
Published: 2009-05-03
License: https://open.fda.gov/license/

Monarch Labs, LLC / initiated 2009-05-03 / Terminated

FDA source

Monarch Labs, LLC began a recall of Monarch Labs Medical Maggots with the accessory LeFlap dressing (previously known as Creature Comforts II), 250-500 per vial, Batch #: MM-090406 with... on 2009-05-03. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2207-2010
Status: Terminated
Initiated: 2009-05-03
Posted: 2010-08-11
Terminated: 2012-12-13
Recalling firm: Monarch Labs, LLC
Product: 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.
Product code: NQK Maggots, Medical
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 root cause: Other
Action: 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" .
Quantity in commerce: 14 vials
Distribution: Nationwide Distribution -- CA, IA, KY, IL, TX, SC & UT.
Product codes and lots: Batch #: MM-090406 with CCII-0901

Product code NQK

K072438UnclassifiedMedical Maggots, Creature ComfortsMonarch Labs, LLC / cleared 2007-10-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)