CLASS II Device recall · Reported 7 Jun 2017 · FDA Enforcement Report

Peg, Peg Kit, For Enteral Use Only, Sterile recalled by AbbVie

AbbVie is recalling Peg, Peg Kit, For Enteral Use Only, Sterile, distributed nationwide in the US. The recall was initiated on 27 Apr 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesMaterial/List number: 629100116 Lots: 32025235, 32184275, 32354106, 32365305, 32435265

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2177-2017
FDA event ID: 77129
Recalling firm: AbbVie, North Chicago, IL
Classification: Class II
Status: Terminated
Recall initiated: 27 Apr 2017
FDA classified: 31 May 2017
Reported: 7 Jun 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

27 Apr 2017	Recall initiated by company
31 May 2017	Classified by FDA	+34 days
7 Jun 2017	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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

Nationwide

Questions about this recall

Why was it recalled?

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.

Which lots are affected?

Material/List number: 629100116 Lots: 32025235, 32184275, 32354106, 32365305, 32435265

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 77129

This product is part of a recall event; the main page for the event is Peg, Peg Kit, For Enteral Use Only, Sterile recalled by AbbVie.

Reported	Class	Recall	Company	Reason	Where
7 Jun 2017	CLASS II	Peg, Peg Kit, For Enteral Use Only, Sterile recalled by AbbVie	AbbVie	Labeling Errors	Nationwide
7 Jun 2017	CLASS II	Peg, Peg Kit, For Enteral Use Only, Sterile recalled by AbbVie	AbbVie	Other	Nationwide

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