Recall Z-1610-2024— ROUTE 92 MEDICAL INC

Name: FDA recall Z-1610-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-08

Class I · Ongoing

Class I FDA medical device recall by ROUTE 92 MEDICAL INC, initiated 2024-03-08. It names one FDA 510(k) clearance: K222743. Product: Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.. Reason: Their is the potential for distal tip separation at the proximal marker band of the delivery catheters..

Recalling firm: ROUTE 92 MEDICAL INC
Classification: Class I
Status: Ongoing
Initiated: 2024-03-08
Firm location: San Mateo, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K222743 — Route 92 Medical Full Length 070 Access SystemRoute 92 Medical, Inc.·cleared 2022-10-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.