Home / Recalls / Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. / Z-0681-2018

Z-0681-2018 Class II Terminated

Recalled by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. — Dover, NH

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
156

Product Description

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

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: 1706049D

Other recalls by Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

  • Z-0585-2020 Class II — 4Fr x 20cm Single Lumen CT Midline Basic Tray, Product Code: VYML4S1001 (September 24, 2019)
  • Z-0933-2018 Class II — Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Ki (October 3, 2017)
  • Z-0682-2018 Class II — 3-Way Standardbore Stopcock. Product Code: AMS-100. (July 24, 2017)
  • Z-0678-2018 Class II — Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M (July 24, 2017)
  • Z-0679-2018 Class II — 20Ga x .75 LifeGuard Huber Needle with Y-site. Product Code: CLGY-2034. (July 24, 2017)
  • Z-0680-2018 Class II — CVC Tray Pediatrics. Product Code: AMS-9335CP-2. (July 24, 2017)
  • Z-1484-2017 Class II — AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used (February 20, 2017)
  • Z-0787-2017 Class II — AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 (November 18, 2016)