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Recall Observatory FDA recall evidence

Device product

AbbVie PEG Kit 20 FR

Z-0786-2017

November 22, 2016

Class II

Product summary

Firm
AbbVie Inc.
Event
Event 75794
Status
Terminated
Classification
Class II
Quantity
541 units
Official record key
device-enforcement:Z-0786-2017

Official wording

Reason: AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors.

Code information: AbbVie PEG Kit 20 Fr Product Code 62912-01-16 with lot numbers: 32025245, 32265215, 32335206, 32335336

Distribution pattern: U.S. consignees located throughout the country and Puerto Rico. Foreign Consignees: Worldwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    AbbVie is issuing an urgent field correction notification due to an increased number of reports of disconnections of the AbbVie 20FR PEG tube from the Y-connectors.