Recall Z-2177-2017— AbbVie Inc.

Name: FDA recall Z-2177-2017
Creator: U.S. Food and Drug Administration
Published: 2017-04-27

Class II · Terminated

Class II FDA medical device recall by AbbVie Inc., initiated 2017-04-27, terminated 2019-07-09. It names one FDA 510(k) clearance: K142793. Product: AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.. 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..

Recalling firm: AbbVie Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-04-27
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, 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.

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