Reported Jan 18, 2023 · Ongoing
MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only
Covidien LP
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: Covidien LP · 15 Hampshire St · Mansfield, MA · 02048-1113
Is this the product you have?
MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only
16 of 16 products
| Model / number | Product as published |
|---|---|
8888135131 | 13.5 cm, Curved Extensions, Kit |
8888135132 | 13.5cm, Pre-Curved, Kit |
8888135133 | 13.5cm, Straight Extensions, IC Tray |
8888135134 | 16cm, Straight Extensions, Kit |
8888135161 | 16cm, Curved Extensions, Kit |
8888135162 | 16 cm, Pre-Curved, Kit |
8888135163 | 16cm, Straight Extensions, IC Tray |
8888135164 | 19.5cm, Straight Extensions, Kit |
8888135191 | 19.5cm, Curved Extensions, Kit |
8888135192 | 19.5cm, Pre-Curved, Kit |
8888135193 | 19.5cm, Straight Extensions, IC Tray |
8888135194 | 19.5cm, Curved Extensions, PASS Tray |
8888135198 | 24cm, Straight Extensions, Kit |
8888135241 | 24cm, Curved Extensions, Kit |
8888135242 | 24cm, Pre-Curved, Kit |
8888135243 | — |
- Amount recalled
- 359,730 (23,003 US; 336,727 OUS)
Where it was sold
- Nationwide
- PR
Why it was recalled
Stop using this product now
There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
Using this product could cause serious injury, illness or death — stop using it now.
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