Recall Z-0786-2017— AbbVie Inc.

Name: FDA recall Z-0786-2017
Creator: U.S. Food and Drug Administration
Published: 2016-11-22

Class II · Terminated

Class II FDA medical device recall by AbbVie Inc., initiated 2016-11-22, terminated 2019-07-09. It names one FDA 510(k) clearance: K142793. Product: AbbVie PEG Kit 20 FR. 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..

Recalling firm: AbbVie Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-11-22
Terminated: 2019-07-09
Firm location: North Chicago, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K142793 — AbbVie PEGAbbVie , Inc.·cleared 2015-01-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AbbVie PEG Kit 20 FR

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.