| Class 2 Device Recall 20Ga x .75 LifeGuard Huber Needle with Ysite | |
Date Initiated by Firm | July 24, 2017 |
Create Date | February 21, 2018 |
Recall Status1 |
Terminated 3 on November 07, 2019 |
Recall Number | Z-0679-2018 |
Recall Event ID |
78951 |
510(K)Number | K013871 |
Product Classification |
Set, administration, intravascular - Product Code FPA
|
Product | 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034. |
Code Information |
Lot Number: 1706017D |
Recalling Firm/ Manufacturer |
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. 87 Venture Dr Dover NH 03820-5914
|
Manufacturer Reason for Recall | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being
initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the
Tyvek may not be coated completely causing gaps in the adhesive used to seal the product packaging.
This potential lack of adhesive may affect the sterility of the product. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | Vygon sent recall letters dated July 24, 2017, to customers via email and fax with read receipts and delivery confirmations. The recall letter informed customers of the reason for recall, product description, code and lot number, and instructions to customers, with a Recall Acknowledgement and Inventory Return Form provided/accompanying the recall letter. |
Quantity in Commerce | 396 units |
Distribution | U.S. |
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 = FPA
|
|
|
|