Recall Z-2211-2017 ยท LKB Pad, Alcohol, Device Disinfectant
Madison Polymeric Engineering
Draco Enzymatic Deep-Cleaning Pad with Enzymatic Detergent Catalogue Number: HY0305Z
| Date | May 12, 2017 (initiated Apr 17, 2017) |
| Status | Terminated |
| 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 cust |
| Quantity | 5 cases |
| Distribution | Distributed in the US. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.