Home / Recalls / Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. / Z-0787-2017

Z-0787-2017 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
December 28, 2016
Initiation Date
November 18, 2016
Termination Date
October 23, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
31,500

Product Description

AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to administer medical fluids.

Reason for Recall

Incorrect priming volume is printed on the device package.

Distribution Pattern

US distribution in the state of CA

Code Information

1601064D 1603065D 1605009D 1606038D 1607016D 1607072D 1608067D 1609069D

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-0681-2018 Class II — 19Ga x 1 Huber Needle Set. Product Code: MBS-1910. (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-0682-2018 Class II — 3-Way Standardbore Stopcock. Product Code: AMS-100. (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)