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.
Enforcement
- Recall Number
- Z-0026-2015
- Event ID
- 69085
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Navilyst Medical, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 15, 2014
- Initiation Date
- August 25, 2014
- Classification Date
- October 6, 2014
- Termination Date
- March 10, 2017
- Address
- 10 Glens Falls Technical Park, Glens Falls, NY, 12801, United States
Description
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.
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.
Batch/Lot Nos. 4745699 (exp. 31-Jan-16) and 4760237 (31-Jan-16)
Nationwide Distribution
300 units/pouches