Recall Z-1925-2019 ยท MNL Accessories, Cleaning Brushes, For Endoscope
Madison Polymeric Engineering
First Step Draco Pad, Product Number EP-4D
| Date | May 8, 2019 |
| Status | Terminated |
| Reason | This product has been contaminated with Stenotrophomonas lactiubi. |
| Root cause | Under Investigation by firm |
| Action | Urgent Medical Device Recall notification letters dated 5/8/19 were sent to customers. |
| Quantity | 10570 |
| Distribution | The products were distributed to the following US states: AZ, CA, FL, IA, IL, IN, MA, MD, MO, PA, TN, TX, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.