Device product
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
Z-0714-2017
Product summary
- Event
- Event 74948
- Status
- Terminated
- Classification
- Class II
- Quantity
- 48 cartons (boxes of 5)
- Official record key
device-enforcement:Z-0714-2017
Official wording
Reason: 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.
Code information: Lot #: 4941411
Distribution pattern: Nationwide Distribution to CA, FL, GA, HI, LA, MI, MN, MO, NV, OH & TX
Derived failure modes
-
Unknown
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.