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.
Recall
- Recall Number
- Z-0076-2019
- Event Number
- 80913
- Firm
- Angiodynamics Inc. (Navilyst Medical Inc.)
- FEI Number
- 3017892510
- Product Code
- LJT
- Status
- Terminated
- Root Cause
- Unknown/Undetermined by firm
- Initiated
- July 24, 2018
- Terminated
- May 17, 2019
- Address
- 10 Glens Falls, Tech Park Glens Falls, NY, 12801-3864
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.
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
On July 24, 2018 AngioDynamics initiated this recall action by notifying the affected consignee via telephone call.Per the telephone conversation, the consignee was instructed to segregate the affected device and quarantine the product until further direction from AngioDynamics. A follow-up letter issued dated 7/24/18 email response form to be completed and returned.
US Nationwide in the state of IN.
1 box