Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.: Medical Device Recall in 2016 - (Recall #: Z-0787-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 18, 2016

Date Posted: December 28, 2016

Recall Number: Z-0787-2017

Event ID: 75816

Reason for Recall:

Incorrect priming volume is printed on the device package.

Status: Terminated

Product Quantity: 31,500

Code Information:

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

Distribution Pattern:

US distribution in the state of CA

Voluntary or Mandated:

Voluntary: Firm initiated