| Class 2 Device Recall BioFlo Port with ENDEXO and PASV Valve Technology | |
Date Initiated by Firm | September 18, 2019 |
Create Date | November 21, 2019 |
Recall Status1 |
Terminated 3 on September 24, 2020 |
Recall Number | Z-0502-2020 |
Recall Event ID |
83907 |
510(K)Number | K122767 |
Product Classification |
Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
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Product | BIOFLO 8F SINGLE TITANIUM NON- FILLED; VALVED, UPN H965440250, Cat. No. 44-025 - 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 |
5488012 |
Recalling Firm/ Manufacturer |
Angiodynamics Inc. (Navilyst Medical Inc.) 10 Glens Falls Tech Park Glens Falls NY 12801-3864
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For Additional Information Contact | David Greer 518-795-1676 |
Manufacturer Reason for Recall | Snap lock connectors provided within implantable port kits may not meet dimensional specifications, and the catheter cannot be inserted into the snap lock connector prior to connection to the port chamber, resulting in a delay to the implantation procedure. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | On September 18, 2019, AngioDynamics sent Urgent Voluntary Medical Device Letters to impacted consignees. Customers were asked to do the following:
IMMEDIATELY
o Stop using the product subject to recall.
o Remove any affected (recalled) product from your inventory (whether in labs, Central
Supply, Shipping and Receiving or ANY other location).
o Segregate this product in a secure location for return to AngioDynamics, Inc.
o Forward a copy of this recall notification to all sites to which you have distributed
affected product.
IN THE EVENT THAT THE PORT PRODUCT UNDER RECALL HAS BEEN UTILIZED (IMPLANTED)
o The occurrence rate of an out of specification snap lock connector is less than 100%.
o A port kit containing a properly sized snap lock connector allows the catheter to be
securely attached to the port.
o There are no actions required for an implanted port with a properly attached catheter.
Customers were asked to complete and return the Reply Verification Form, and to package and return the recalled product. |
Quantity in Commerce | 582 |
Distribution | Worldwide distribution - US Nationwide in the state of CA, CT, FL, GA, IA, IN, KS, KY, MI, MO, MS, MT, NE, NJ, NY, OH, OK, OR, PA, TN, TX, WA, WI and country of Canada. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = LJT
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