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U.S. Department of Health and Human Services

Class 2 Device Recall BioFlo Port with ENDEXO and PASV Technology

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  Class 2 Device Recall BioFlo Port with ENDEXO and PASV Technology see related information
Date Initiated by Firm July 24, 2018
Create Date October 05, 2018
Recall Status1 Terminated 3 on May 17, 2019
Recall Number Z-0076-2019
Recall Event ID 80913
510(K)Number K131694  
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Product 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.
Code Information Lot Number: 5363172
Recalling Firm/
Manufacturer		 Angiodynamics Inc. (Navilyst Medical Inc.)
10 Glens Falls Tech Park
Glens Falls NY 12801-3864
For Additional Information Contact SAME
518-792-4112
Manufacturer 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
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action 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.
Quantity in Commerce 1 box
Distribution US Nationwide in the state of IN.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LJT and Original Applicant = NAVILYST MEDICAL, INC.
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