Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0681-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

19Ga x 1 Huber Needle Set. Product Code: MBS-1910.

Product Classification:

Class II

Date Initiated: July 24, 2017

Date Posted: February 28, 2018

Recall Number: Z-0681-2018

Event ID: 78951

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.

Status: Terminated

Product Quantity: 156

Code Information:

Lot Number: 1706049D

Distribution Pattern:

U.S.

Voluntary or Mandated:

Voluntary: Firm initiated