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U.S. Department of Health and Human Services

Class 1 Device Recall Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set

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  Class 1 Device Recall Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set see related information
Date Initiated by Firm March 08, 2024
Date Posted April 24, 2024
Recall Status1 Open3, Classified
Recall Number Z-1611-2024
Recall Event ID 94270
510(K)Number K223530  
Product Classification Catheter, thrombus retriever - Product Code NRY
Product Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.
Code Information UDI: 00853799007497/ Lot # 223060102, 24010102, 23070501, 24010903, 23082802 24011606 , 23100404, 24012403 , 23110901
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 750 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
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 = NRY and Original Applicant = Route 92 Medical, Inc.
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