Medical device recalls Moderate risk

CME America, LLC recalls BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP

Recall date
January 16, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1126-2015
FDA classification
Class II
Brand / firm
CME America, LLC
Sold / distributed
Worldwide Distribution - Nationwide Distribution and VA/military/govt consignees and the country of Canada.

Why it was recalled

CME America is recalling the BodyGuard and BodyGuard 323 Infusion pumps due to the potential for an over delivery.

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

What was recalled

BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP

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