Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for introduction of interventional devices into

FDA device recall Z-1612-2024 · posted 2024-04-24 · Open, Classified

Recall details

Recalling firm

ROUTE 92 MEDICAL INC

Reason for recall

Their is the potential for distal tip separation at the proximal marker band of the delivery catheters

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

QJP

Quantity affected

117 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

Date initiated

2024-03-08

Date posted

2024-04-24

Location

San Mateo, CA

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