Facility

Draegerwerk AG & Co. KGaA

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

Key facts

1recalls · 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)	3001104093
Establishment type	Repack or Relabel Medical Device
Location	53/55 MOISLINGER ALLEE LUEBECK Schleswig-Holstein, DE 23542
Registration status	Active · expires 2026
Parent company	Draegerwerk AG & Co. KGaA (owner-operator 8010046)
Brand names	Infinity C700 for IT

Activity by year

Recalls (1)

Devices registered here (1)

System, Network And Communication, Physiological Monitors
Product code MSX (opens in a new tab) · Class II · Cardiovascular · 21 CFR 870.2300

Recalls & enforcement

Class IIOngoing2023-11-17
Internal backup battery may fail spontaneously while the Atlan is being operated without AC mains supply, resulting in unexpected shutdown of the device while running on batteries.

All facilities operated by Draegerwerk AG & Co. KGaA

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. “Draegerwerk AG & Co. KGaA (FEI 3001104093) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001104093-draegerwerk-ag-co-kgaa/

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