Reported Dec 14, 2016 · Terminated
Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are…
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?
- Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring
- Lot codes and dates
- Lot #: 4941411
- Amount recalled
- 48 cartons (boxes of 5)
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
There is a potential for stylet stiffening that is not accurately represented on the labeling. The label states that product includes a stylet with an outside diameter (OD) measuring 0.014, however, the product may contain a stylet with an outside diameter (OD) measuring 0.016.
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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