FDAFDA · Food and drugs·Recall number Z-0026-2015
BioFlo PICC with ENDEXO Technology and PASV Valve Technology Maximal Barrier Nursing Kit, 5F-55 cm, UPN Product No. H965750191, REF/Catalog No. 75-019, STERILE --- 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.
Published October 15, 2014 · Recall initiated: August 25, 2014
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
NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Navilyst Medical, Inc
- Distributor
- Nationwide Distribution
- Lot
- Batch/Lot Nos. 4745699 (exp. 31-Jan-16) and 4760237 (31-Jan-16)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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