Home / Recalls / Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. / Z-0933-2018

Z-0933-2018 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
March 21, 2018
Initiation Date
October 3, 2017
Termination Date
January 6, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
21350

Product Description

Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. Kit used when administering IV during emergency.

Reason for Recall

The Iodine Prep Pads within the Vygon IV Start Convenience Kits, had stability samples that were not meeting iodine assay level requirements to support the 36 month expiration date. All kits containing the affected pads were recalled.

Distribution Pattern

US Distribution.

Code Information

AMS-623T-6 (1506075D, 1508057D, 1511030D, 1604024D, 1605080D, 1610017D, 1706097D, 1707055D) and AMS-626TGSLF (1601102D, 1603099D, 160581D, 1607019D, 1610057D, 1703068D, 1703069D, 1704065d, 1706076D, 1707031d, 1707056D)

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-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-0681-2018 Class II — 19Ga x 1 Huber Needle Set. Product Code: MBS-1910. (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)