Medical device recalls Moderate risk

Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. recalls AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids.

Recall date
February 20, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1484-2017
FDA classification
Class II
Brand / firm
Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Sold / distributed
US Nationwide Distribution in the states of NJ, TX, VA, FL, VA, MA, IL, MI, NY, OH, WA, PA, WV

Why it was recalled

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

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