FDA Medical Device Recalls (openFDA)
Madison Polymeric Engineering: Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z
- Recall number
- Z-2211-2017
- Recalling firm
- Madison Polymeric Engineering
- Product
- Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z
- Status
- Terminated
- Initiated
- 2017-04-17
- Posted
- 2017-05-12
- Terminated
- 2017-09-21
- Reason
- Product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae.
- 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
- 5 cases
- Distribution
- Distributed in the US.
- Lot, serial or model codes
- Lot Number: EXP20180616 and EXP20180622
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LKB
- Firm FEI
- 3001451466
- Firm city
- Branford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28