Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1484-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.

Product Classification:

Class II

Date Initiated: February 20, 2017

Date Posted: March 29, 2017

Recall Number: Z-1484-2017

Event ID: 76607

Reason for Recall:

Incorrect priming volume printed on the device package.

Status: Terminated

Product Quantity: 30,700

Code Information:

1610092D 1611091D 1612068D 1612074D

Distribution Pattern:

US Nationwide Distribution in the states of NJ, TX, VA, FL, VA, MA, IL, MI, NY, OH, WA, PA, WV

Voluntary or Mandated:

Voluntary: Firm initiated