Facility

BREAS MEDICAL AB

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

Key facts

1recalls · worst Class II

1inspections · worst VAI

—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)	3003244771
Establishment type	Develop Specifications But Do Not Manufacture At This Facility; Export Device to the United States But Perform No Other Operation on Device
Location	FORETAGSVAGEN 1 MOLNLYCKE Vastra Gotaland, SE 43533
Registration status	Active · expires 2026
Parent company	Breas Medical (owner-operator 10046282)
Brand names	Single Patient Breathing Hose, Breathing Therapy Equipment Patient Circuit, Single Limb with Leakage Port, Disposable, B

Activity by year

Recalls (1)
Inspections (1)

Devices registered here (1)

Set, Tubing And Support, Ventilator (W Harness)
Product code BZO (opens in a new tab) · Class I · Anesthesiology · 21 CFR 868.5975

Recalls & enforcement

Class IITerminated2014-11-07
Unintended treatment termination could result from a keypad malfunction in some situations. The device erroneously interprets this as a Stop Treatment Instruction. An alarm will not sound, or be registered. Accessories and monitoring equipment connected to the Vivo 50 will stop f…

FDA inspections (1)

VAI2022-08-10
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

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. “BREAS MEDICAL AB (FEI 3003244771) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3003244771-breas-medical-ab/

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