Recall Z-0025-2020 ยท EOQ Bronchoscope (Flexible Or Rigid)
AURIS HEALTH INC
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
| Date | Apr 19, 2019 |
| Status | Terminated |
| Reason | Reports of aspirating biopsy needle breakage |
| Root cause | Labeling design |
| Action | On 04/19/19, Urgent Medical Device Notifications were mailed to customers. Customers were advised the following: Please review the updated instructions for use for proper insertion, along with updated and warnings/cautions related to the use of the device. Specifically, the following instructions were included: " Do NOT use excessive insertion force if resistance is encountered during insertion of the needle through the bronchoscope working channel. Excessive force may cause damage to either the device or the bronchoscope working channel. " DO inspect the needle sharp for damage prior to use. |
| Quantity | 158 |
| Distribution | US nationwide distribution to the states of: CT, FL, MI, OK, TN, MS, CA, MN, OH, PA, and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173760 | Monarch Endoscopy Platform (Monarch Platform) Auris Surgical Robotics, Inc., Mar 22, 2018 |