Z-2211-2017Class II

Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z

Name: Z-2211-2017 Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z
Creator: Madison Polymeric Engineering
Published: 2017-04-17
License: https://open.fda.gov/license/

Madison Polymeric Engineering / initiated 2017-04-17 / Terminated

FDA source

Madison Polymeric Engineering began a recall of Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z on 2017-04-17. FDA classified it as Class II and gives the reason as "Product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2211-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-17
Posted: 2017-05-12
Terminated: 2017-09-21
Recalling firm: Madison Polymeric Engineering
Product: Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z
Product code: LKB Pad, Alcohol, Device Disinfectant
Reason for recall: Product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae.
FDA root cause: Other
Action: Cygnus Medical sent a first class letter dated April 14, 2017, indicating to discontinue use of HY0305Z Draco Pads with information to return the unused product also included. Our records indicate that you have purchased this lot number. Please check your inventory. The lot number can be found on the individual product pouch and the label on the carton. We have found a mold contaminant and request that you remove the product from use and return to us. We are conducting an investigation. To obtain a return authorization please contact our Quality Department. You may also contact our customer service at (800) 990-7489. We regret any inconvenience this may cause. Please contact Cygnus Medical LLC should you have any questions.
Quantity in commerce: 5 cases
Distribution: Distributed in the US.
Product codes and lots: Lot Number: EXP20180616 and EXP20180622

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2211-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2211-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-06-01

Product code LKB

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)