CLASS II Device recall · Reported 28 Dec 2016 · FDA Enforcement Report

PEG Kit recalled by AbbVie

AbbVie is recalling AbbVie PEG Kit, distributed in Puerto Rico. The recall was initiated on 22 Nov 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAbbVie PEG Kit 20 Fr Product Code 62912-01-16 with lot numbers: 32025245, 32265215, 32335206, 32335336

Quantity recalled541 units

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-0786-2017
FDA event ID: 75794
Recalling firm: AbbVie, North Chicago, IL
Classification: Class II
Status: Terminated
Recall initiated: 22 Nov 2016
FDA classified: 17 Dec 2016
Reported: 28 Dec 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

22 Nov 2016	Recall initiated by company
17 Dec 2016	Classified by FDA	+25 days
28 Dec 2016	Published in enforcement report	+11 days

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

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.

Product as listed by the FDA

AbbVie PEG Kit 20 FR

Where it was distributed

U.S. consignees located throughout the country and Puerto Rico. Foreign Consignees: Worldwide.

Puerto Rico

Questions about this recall

Is PEG Kit recalled?

Yes. AbbVie recalled PEG Kit on 22 Nov 2016. The recall is Class II and its status is Terminated. Recall number Z-0786-2017.

Why was it recalled?

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.

Which lots are affected?

AbbVie PEG Kit 20 Fr Product Code 62912-01-16 with lot numbers: 32025245, 32265215, 32335206, 32335336

Where was it sold?

U.S. consignees located throughout the country and Puerto Rico. Foreign Consignees: Worldwide.

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

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