ROUTE 92 MEDICAL INC 2024-05-01 Health critical FDA
Health · FDA · Recall #FDA-Z-1612-2024
Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for… Recall
Issued May 1, 2024 · ROUTE 92 MEDICAL INC
In May 2024, ROUTE 92 MEDICAL INC recalled the Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
What you should do
- 1 Stop using Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. Used for… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact ROUTE 92 MEDICAL INC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- ROUTE 92 MEDICAL INC
- Category
- Health
- Recall date
- May 1, 2024
- Units affected
- Not reported
- Sold at
- 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
- Recall number
- FDA-Z-1612-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- ROUTE 92 MEDICAL INC has 2 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.