Reported May 1, 2024 · Ongoing
Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional…
Route 92 Medical Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ROUTE 92 MEDICAL INC · 155 Bovet Rd Ste 100 · San Mateo, CA · 94402-3151
Is this the product you have?
- Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature.
- Lot codes and dates
- UDI
00853799007534/ Lot # 23033001230731012307030523081707
- UDI
- Amount recalled
- 200 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
Why it was recalled
Stop using this product now
Their is the potential for distal tip separation at the proximal marker band of the delivery catheters
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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