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FDAFDA · Food and drugs·Recall number Z-2178-2017

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

Published June 7, 2017 · Recall initiated: April 27, 2017

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
AbbVie Inc.
Distributor
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, Slovenia, Slovakia, Turkey
Lot
Material/List number: 62918001 Lots: 32044225, 32155205, 32344326, 32461215
Risk classification
Class II
Area (FDA)
device
Country
United States

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