RegWardenFDA facility compliance records
Recall

Class II — AbbVie Inc.

Recalling firmAbbVie Inc.
Registered facilityView this company's 5 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
Reason
ProductAbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
Quantity673 kits
DistributionNationwide, 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
Initiated2017-04-27
Classified2017-05-31
Terminated2019-07-09
Recall numberZ-2176-2017
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — AbbVie Inc. (Z-2176-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/77129/

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