Reported Nov 27, 2019 · Terminated
BIOFLO 8F SINGLE PLASTIC FILLED; NON-VALVED, UPN H965440140, Cat. No. 44-014 - Product Usage: Long-term access to the…
Angiodynamics Inc. (Navilyst Medical Inc.)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Angiodynamics Inc. (Navilyst Medical Inc.) · 10 Glens Falls Tech Park · Glens Falls, NY · 12801-3864
Is this the product you have?
BIOFLO 8F SINGLE PLASTIC FILLEDNON-VALVEDUPN H965440140Cat. No. 44-014 -
- Product UsageLong-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal
- Lot codes and dates
548793254879335488008
- Amount recalled
- 582
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure.
This product could cause temporary or reversible health problems — stop using it.
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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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