| Class 1 Device Recall 070 Reperfusion System | |
Date Initiated by Firm | March 08, 2024 |
Date Posted | April 24, 2024 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-1614-2024 |
Recall Event ID |
94270 |
Product Classification |
Catheter, percutaneous - Product Code DQY
|
Product | Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in ischemic stroke patients. |
Code Information |
UDI: 00853799007169/ Lot # 23112702 and 23112901 |
Recalling Firm/ Manufacturer |
ROUTE 92 MEDICAL INC 155 Bovet Rd Ste 100 San Mateo CA 94402-3151
|
Manufacturer Reason for Recall | Their is the potential for distal tip separation at the proximal marker band of the delivery catheters |
FDA Determined Cause 2 | Process control |
Action | On March 12, 2024 Route 92, issued a Urgent Medical Device recall notification to affected consignees via Mail and EMail. Route 92 asked consignees to take the following actions:
Ensure all of your SUMMIT MAX inventory including the affected 070 Reperfusion
Systems is in a secure, quarantined location.
2. Complete the Acknowledgement Form in Attachment 2 and return to Route 92
Medical by one of the following methods:
Email-FieldActions@route92medical.com/Standard Mail - Attention Line: Tenzing 7 fiedl action, 155 Bovet Road Suite 100, San Mateo, CA 94402
Please return the Acknowledgement Form even if you no longer have the
product subject to this recall.
4. Immediately return any affected products with the specific lot numbers listed in
Attachment 1 to the address above using the original shipping container or
request a new shipping container and pre-printed shipping label by email.
5. Keep this notice until all product subject to this recall has been returned. While
processing your returns, please maintain a copy of this notice with the
quarantined product subject to this recall and keep a copy for your records.
6. Separately, as part of SUMMIT MAX closure, you will be sending back your
remaining SUMMIT MAX inventory if you haven t done so already. |
Quantity in Commerce | 19 units |
Distribution | US: AL AZ CA DE FL GA IA IL IN KY LA MA MD MI MN MO NC ND NJ NY OH OR PA RI SD TN TX UT VA WV
OUS: New Zealand |
Total Product Life Cycle | TPLC Device Report |
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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.
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