The Recall Desk
HighFDA (Devices)·Z-2211-2017·Announced 2017-06-07

Madison Polymeric Engineering Recalls Contaminated Draco Enzymatic Deep-Cleaning Pads

Madison Polymeric Engineering is recalling Draco Enzymatic Deep-Cleaning Pads due to contamination with Cladosporium cladosporioides/herbarum/phaenocomae.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device contaminated with a pathogen (Cladosporium) without reported illness, fitting the rubric criterion for high-risk pathogens or risk-of-harm products where injury has not yet been reported.

Plain-English summary

Madison Polymeric Engineering is recalling Draco Enzymatic Deep-Cleaning Pads with Enzymatic Detergent, Catalogue Number HY0305Z. The recall involves 5 cases of the product distributed in the US. The affected lot numbers are EXP20180616 and EXP20180622.

The recall was initiated because the product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae. The source text does not specify the exact nature of the health risk associated with this specific fungal contamination or provide details on reported illnesses or injuries.

Consumers who possess these specific lot numbers should stop using the product and contact the recalling firm for instructions on return or disposal.

The recalled product

Product
Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z
Affected units
5

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot Number: EXP20180616 and EXP20180622

Distribution

Distribution scope not specified by the agency.