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U.S. Department of Health and Human Services

Class 2 Device Recall Monarch, Aspirating Biopsy Needle

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  Class 2 Device Recall Monarch, Aspirating Biopsy Needle see related information
Date Initiated by Firm April 19, 2019
Create Date November 16, 2019
Recall Status1 Open3, Classified
Recall Number Z-0025-2020
Recall Event ID 82763
510(K)Number K173760  
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
Product Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120
Code Information Lots:  RS181129-1 RS181129-2 RS181210-1 RS181210-2 RS181210-3 RS181210-4 RS190117-1 RS190125-1 RS190211-1 RS190225-3 RS190308-1 RS190319-1
Recalling Firm/
Manufacturer
AURIS HEALTH INC
150 Shoreline Dr
Redwood City CA 94065-1400
For Additional Information Contact Joy M. Sacmar
650-781-1610
Manufacturer Reason
for Recall
Reports of aspirating biopsy needle breakage
FDA Determined
Cause 2
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. If damage is found, do not use the needle. " Do NOT use the needle if the bronchoscope working channel is damaged, kinked or compromised. Please ensure that all necessary personnel in your facility are made aware of this notification, and please maintain awareness on this notice to ensure effectiveness of the corrective action. Complete and return the Acknowledgement Form. Customers with questions are encouraged to call 1-800-434-0032. On 06/25/19, Urgent Medical Device Recall (Removal) notices were mailed to customers informing them that the recalling firm is in the process of investigating the root cause and they will contact customers when replacement product becomes available. In the meantime, refer to the Compatibility Statement in the User Manual when deciding to use other commercially available needles. Customers were advised: 1.Examine your inventory immediately to determine if you have product lots subject to this recall (removal) on hand and quarantine such product(s). 2. Remove the product lots subject to this recall (removal) and communicate the issue to relevant personnel, or anyone else in your facility who needs to be informed. 3. If any product lots subject to this recall (removal) has been forwarded to another facility, contact that facility to arrange return. 4. Complete the attached Acknowledgement Form confirming receipt of this notice an
Quantity in Commerce 158
Distribution US nationwide distribution to the states of: CT, FL, MI, OK, TN, MS, CA, MN, OH, PA, and IL.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = EOQ and Original Applicant = Auris Surgical Robotics, Inc.
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