Z-0076-2019 Class II Terminated
FDA device recall Z-0076-2019 was initiated by Angiodynamics Inc. (Navilyst Medical Inc.) on Jul 24, 2018 and is designated Class II. 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… The recall status is terminated (terminated May 17, 2019). Affected quantity: 1 box.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 17, 2018
- Initiation Date
- Jul 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0076-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026