Reported Jun 30, 2021 · Terminated
GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
Vero Biotech, LLC
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: Vero Biotech, LLC · 387 Technology Cir Nw Ste 125 · Atlanta, GA · 30313-2411
Is this the product you have?
- GENOSYL DS; Nitric Oxide Delivery System Combination Product NDA202860
- Lot codes and dates
466 of 466 codes
Model #: 601588-01Serial #'s: G0803G0807G0808G0814G0149G0157G0183G0191G0195G0198G0202G0560G0600G0693G0729G0734G0772G0775G0138G0147G0155G0159G0172G0185G0203G0209G0282G0344G0385G0398G0408G0415G0569G0601G0756G0323G0358G0379G0383G0386G0405G0334G0399G0413G0463G0158G0174G0285G0305G0466G0719G0135G0194G0205G0281G0362G0407G0573G0574
- Amount recalled
- 465 units
Where it was sold
Why it was recalled
Stop using this product now
Reports received of NO measured below desired dose during transition between primary console and backup console since Software Version 2.2.3 was uploaded to consoles in the field.
Using this product could cause serious injury, illness or death — stop using it now.
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