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U.S. Department of Health and Human Services

Class 2 Device Recall Bionector Needleless connector

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  Class 2 Device Recall Bionector Needleless connector see related information
Date Initiated by Firm August 28, 2014
Date Posted October 22, 2014
Recall Status1 Terminated 3 on March 30, 2015
Recall Number Z-0113-2015
Recall Event ID 69204
510(K)Number K070705  
Product Classification Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Product Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.
Code Information Product code and lot numbers: Product Code: 896.038, with lot Numbers: 291113EE, 070214EE, 210314EE, 280314EE.
Recalling Firm/
Manufacturer		 Vygon Corporation
2750 Morris Rd Ste A200
Lansdale PA 19446-6083
For Additional Information Contact Customer Support
800-473-5414
Manufacturer Reason
for Recall		 Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless connector.
FDA Determined
Cause 2		 Component design/selection
Action Vygon sent an Urgent Medical Device Recall letter dated August 28, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their stock for the affected product and immediately cease distribution, and quarantine all affected product immediately. Count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form. Customers were asked to fax or email the form to Vygon including customer contact information. Vygon customer service will contact the customer and issue a Return Merchandise Authorization number. Customers were instructed to return the product as well as the original signed Recall Acknowledgement and Inventory Return Form using the instructions from Customer Service involving product pick-up. All inventory will be credited at no cost to the customer. For questions regarding this recall call 800-473-5414.
Quantity in Commerce 42250
Distribution Worldwide Distribution - US including CA and Internationally to CA.
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 = FOZ and Original Applicant = VYGON CORP.
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