FDAFDA · Food and drugs·Recall number Z-0714-2017
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
Published December 14, 2016 · Recall initiated: June 8, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Angiodynamics Inc. (Navilyst Medical Inc.)
- Distributor
- Nationwide Distribution to CA, FL, GA, HI, LA, MI, MN, MO, NV, OH & TX
- Lot
- Lot #: 4941411
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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