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ROUTE 92 MEDICAL INC recall records

5 reported ongoing

5 records in this archive. Latest source date Mar 8, 2024.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

Mar 8, 2024FDA device enforcement

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

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

Class IReported ongoing

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

Official source

Mar 8, 2024FDA device enforcement

Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature.

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

Class IReported ongoing

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

Official source

Mar 8, 2024FDA device enforcement

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

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

Class IReported ongoing

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

Official source

Mar 8, 2024FDA device enforcement

Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.

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

Class IReported ongoing

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

Official source

Mar 8, 2024FDA device enforcement

Route 92 Medical 070 Reperfusion System, REF 1003, Rxonly, SterileEO. Used for introduction of interventional devices into the neurovasculature and aspiration of thrombus in isc...

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

Class IReported ongoing

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

Official source

Reasons in these listed records

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

These examples come from this result page and are not a ranking of every recall reason.

Checking ROUTE 92 MEDICAL INC

Is there a recall on route 92 medical inc right now?

This archive contains 5 records, including 5 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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