Medical device recalls Moderate risk

AbbVie Inc. recalls AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.

Recall date
April 27, 2017
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2178-2017
FDA classification
Class II
Brand / firm
AbbVie Inc.
Sold / distributed
Nationwide, Albania, Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Ireland, Italy, Japan, Korea, Luxembourg, Netherlands, Norway, Portugal, Romania, Russia, Saudi Arabia, Sweden…

Why it was recalled

PEG kits have the potential for one of the following defects: missing components, duplicate components or missing label/Instructions for Use, which includes expiry information.

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

What was recalled

AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.

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