Food, drugs, devices › AbbVie Inc.
Device recall: AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only.
FDA enforcement event 77129 is a device recall by AbbVie Inc. of North Chicago, IL, initiated 27 Apr 2017 and classified Class II, with 3 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 9 Jul 2019. Initiation: voluntary: firm initiated. AbbVie Inc. has 12 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
AbbVie Inc., North Chicago, IL.
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."
Distribution
"Nationwide, Albania, Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Ireland,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2176-2017 | AbbVie PEG, PEG Kit 20FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. | 673 kits | Class II | Terminated | 7 Jun 2017 |
| Z-2177-2017 | AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. | — | Class II | Terminated | 7 Jun 2017 |
| Z-2178-2017 | AbbVie PEG, PEG Kit 15FR, FOR ENTERAL USE ONLY, STERILE, Rx Only. | 3,331 kits | Class II | Terminated | 7 Jun 2017 |
Context
Other enforcement events for AbbVie Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide, Albania, Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Ireland,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 9 Jul 2019. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.