Facility

AbbVie Ireland NL B.V. Ballytivnan

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

—inspections in our data

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3012441529
Establishment type	Manufacture Medical Device for Another Party (Contract Manufacturer)
Location	Ballytivnan Sligo, IE N/A
Registration status	Active · expires 2026
Parent company	AbbVie Inc. (owner-operator 10046068)
Brand names	Coolsculpting System

Activity by year

Recalls (2)

Devices registered here (1)

Dermal Cooling Pack/Vacuum/Massager
Product code OOK (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4340

Recalls & enforcement

Class IITerminated2017-04-27
Class IITerminated2016-11-22
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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “AbbVie Ireland NL B.V. Ballytivnan (FEI 3012441529) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3012441529-abbvie-ireland-nl-b-v-ballytivnan/

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