Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. recalls AMS-651, 120" Microbore extension set with slide clamp; Product Code: AMS-651 Product Usage: Accessory devices used to…

Recall date

November 18, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0787-2017

FDA classification

Class II

Brand / firm

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.

Sold / distributed

US distribution in the state of CA

Why it was recalled

Incorrect priming volume is printed on the device package.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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