Z-2178-2017Class II

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

Name: Z-2178-2017 AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only
Creator: AbbVie Inc.
Published: 2017-04-27
License: https://open.fda.gov/license/

AbbVie Inc / initiated 2017-04-27 / Terminated / root cause: labeling and UDI

FDA source

AbbVie Inc. began a recall of AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only on 2017-04-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2178-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-27
Posted: 2017-05-31
Terminated: 2019-07-09
Recalling firm: AbbVie Inc
Product: AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
Product code: KNT Tubes, Gastrointestinal (And Accessories)
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: On April 27, 2017, firm sent letter (and response form) to customers, instructing them to inspect their inventory for affected lots and arrange a replacement kit to be delivered by AbbVie if a kit with missing components is discovered. Distributors were asked to notify their customers. Any returned affected product will be destroyed.
Quantity in commerce: 3,331 kits
Distribution: 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
Product codes and lots: Material/List number: 62918001 Lots: 32044225, 32155205, 32344326, 32461215

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2178-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2176-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-05-31
Z-2177-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-05-31
Z-2178-2017	Class II	Terminated	Voluntary: Firm initiated	2017-06-07	2017-05-31

Product code KNT

K142793Class IIAbbVie PEGAbbVie , Inc. / cleared 2015-01-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)