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U.S. Department of Health and Human Services

Class 2 Device Recall BioFlo Port with ENDEXO and PASV Valve Technology

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  Class 2 Device Recall BioFlo Port with ENDEXO and PASV Valve Technology see related information
Date Initiated by Firm September 18, 2019
Create Date November 21, 2019
Recall Status1 Terminated 3 on September 24, 2020
Recall Number Z-0505-2020
Recall Event ID 83907
510(K)Number K122767  
Product Classification Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
Product XCELA, 8F SINGLE PLASTIC PORT FILLED, VALVED, UPN H965440400, Cat. No. 44-040 - 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 5480564
Recalling Firm/
Manufacturer		 Angiodynamics Inc. (Navilyst Medical Inc.)
10 Glens Falls Tech Park
Glens Falls NY 12801-3864
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
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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