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Terminated

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

FDA Recall Z-2211-2017 · Posted 2017-05-12

Recalling FirmMadison Polymeric Engineering
Recall StatusTerminated
Product CodeLKB
Date Initiated2017-04-17
Date Terminated2017-09-21
Product Quantity5 cases

Reason for Recall

Product is contaminated with Cladosporium cladosporioides/herbarum/phaenocomae.

Firm 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.

Root Cause

Other

Distribution Pattern

Distributed in the US.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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