Z-0786-2017Class II

AbbVie PEG Kit 20 FR

Name: Z-0786-2017 AbbVie PEG Kit 20 FR
Creator: AbbVie Inc.
Published: 2016-11-22
License: https://open.fda.gov/license/

AbbVie Inc / initiated 2016-11-22 / Terminated / root cause: design

FDA source

AbbVie Inc. began a recall of AbbVie PEG Kit 20 FR on 2016-11-22. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0786-2017
Classification: Class II
Status: Terminated
Initiated: 2016-11-22
Posted: 2016-12-17
Terminated: 2019-07-09
Recalling firm: AbbVie Inc
Product: AbbVie PEG Kit 20 FR
Product code: KNT Tubes, Gastrointestinal (And Accessories)
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.
Root cause tag: design
FDA root cause: Device Design
Action: The firm sent an URGENT: MEDICAL DEVICE FIELD CORRECTION NOTIFICATION AbbVie PEG Kit 20 FR to affected customers describing the reason for the notification. The letter asks affected customers to forward this letter to all Movement Disorder Specialists and physicians (e.g. GIs, IRs, and surgeons) that place PEG- J Tubes within your facility. The letter describes actions to be taken for patients still using the AbbVie PEG 20FR Tube. The letter requests user facilities to continue to monitor the performance of the Tube. The firm states that there is no need to replace the AbbVie PEG 20FR Tube if it is functioning as expected and maintaining a viable connection with the Y-Connector. The letter provides the following instructions when establishing a connection between Abbvie PEG 20FR Tube with the 20FR Y-connector, always refer to AbbVie J Intestinal Tube 9 FR to PEG 15 and 20 FR Instructions for Use for 62918-001. The letter notes the following: 1. Ensure that the set-up process clearly follows the sequence of events as described in the instructions for use and the following clarifications. 2. Ensure that the AbbVie PEG 20FR tube is connected to the corresponding 20 Y- connector (see photograph below which shows the difference between the 15FR and 20FR connection diameter). 3. DO NOT USE ALCOHOL CONTAINING PRODUCTS with the AbbVie PEG 20 FR tube as this may result in damage to the tube. 4. Ensure that the Tube Clamp and Tube Clip on Fixation Plate are both closed. 5. Cut off the proximal cone and Fixation Loop of the AbbVie PEG Tube (15FR or 20FR). Note: Ensure that the cut is perpendicular (90 degree angle) to the tube and not on a diagonal as this ensures proper seating of the tube when engaged into the pin of the Y-connector fitting. 6. Slide the colored Fixation Screw (including the outer ring) over the Abbvie PEG Tube: a. For 15 FR, use the Blue/White screw b. For 20 FR, use the Violet/White screw 7. Grasp near the
Quantity in commerce: 541 units
Distribution: U.S. consignees located throughout the country and Puerto Rico. Foreign Consignees: Worldwide.
Product codes and lots: AbbVie PEG Kit 20 Fr Product Code 62912-01-16 with lot numbers: 32025245, 32265215, 32335206, 32335336

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0786-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0786-2017	Class II	Terminated	Voluntary: Firm initiated	2016-12-28	2016-12-17

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)