Z-0679-2018 Class II Terminated
FDA device recall Z-0679-2018 was initiated by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. on July 24, 2017 and is designated Class II. 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 Ty… The recall status is terminated (terminated November 7, 2019). Affected quantity: 396 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 28, 2018
- Initiation Date
- July 24, 2017
- Termination Date
- November 7, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 396 units
Product Description
20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034.
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.
Distribution Pattern
U.S.
Code Information
Lot Number: 1706017D