Z-0076-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 17, 2018
- Initiation Date
- July 24, 2018
- Termination Date
- May 17, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 box
Product Description
BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - Product Usage - Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.
Reason for Recall
BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have been, 8F SL BioFlo Plastic Valved Non-Filled
Distribution Pattern
US Nationwide in the state of IN.
Code Information
Lot Number: 5363172