Z-2177-2017 Class II Terminated

Recalled by AbbVie Inc. — North Chicago, IL

Recall Details

Product Type
Devices
Report Date
June 7, 2017
Initiation Date
April 27, 2017
Termination Date
July 9, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

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

Reason for Recall

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.

Distribution Pattern

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

Code Information

Material/List number: 629100116 Lots: 32025235, 32184275, 32354106, 32365305, 32435265