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Recall Observatory FDA recall evidence

Device product

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

Z-2177-2017

April 27, 2017

Class II

Product summary

Firm
AbbVie Inc.
Event
Event 77129
Status
Terminated
Classification
Class II
Quantity
Unavailable
Official record key
device-enforcement:Z-2177-2017

Official wording

Reason: 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.

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

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

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    missing label