FDA (Devices) recall action 81874

Draeger Medical, Inc. recalled 9 products on 2019-01-30

The FDA (Devices) publishes a recall like this one as 9 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 9 pages.

Products: 9
Announced: 2019-01-30
Critical: 1
Units: 1,200

Why these products were recalled

Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–9 of 9

SevereFDA (Devices)··2019-01-30
Draeger Medical Recalls VentStar Basic 180 Breathing Circuits
Draeger Medical is recalling 325 units of VentStar Basic 180 breathing circuits due to incorrect pre-assembly that may cause incorrect connections.
Product
VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets…
Category
Distribution
12 states
SevereFDA (Devices)··2019-01-30
Draeger Medical Recalls VentStar Basic Breathing Circuits Due to Assembly Error
Draeger Medical is recalling 525 units of VentStar Basic (P) 180 breathing circuits because they were incorrectly pre-assembled, posing a risk of incorrect connection or short circuiting.
Product
VentStar Basic (P) 180, Catalog Number MP00351 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia…
Category
Distribution
12 states
SevereFDA (Devices)··2019-01-30
Draeger Medical Recalls VentStar Watertrap Breathing Circuits Due to Assembly Error
Draeger Medical is recalling 25 units of VentStar Watertrap (P) 180 breathing circuits because they were incorrectly pre-assembled, posing a risk of incorrect connection.
Product
VentStar Watertrap (P) 180, Catalog Number MP00361 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia…
Category
Distribution
12 states
SevereFDA (Devices)··2019-01-30
Draeger Medical Recalls ID Circuit Watertrap Breathing Circuits Due to Assembly Error
Draeger Medical is recalling 25 units of ID Circuit Watertrap breathing circuits because they were incorrectly pre-assembled, creating a risk of incorrect connection or short circuit.
Product
ID Circuit Watertrap (P) 180, Catalog Number MP01341 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing…
Category
Distribution
12 states
SevereFDA (Devices)··2019-01-30
Draeger ID Circuit Basic 180 Breathing Circuits Recalled for Assembly Defect
Draeger Medical is recalling 25 units of ID Circuit Basic 180 breathing circuits due to incorrect pre-assembly that may cause connection errors.
Product
ID Circuit Basic 180, Catalog Number MP01350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets…
Category
Distribution
12 states
SevereFDA (Devices)··2019-01-30
Draeger Medical Recalls ID Circuit Basic 250 Breathing Circuits
Draeger Medical is recalling 20 units of ID Circuit Basic 250 breathing circuits due to incorrect pre-assembly that may cause connection errors.
Product
ID Circuit Basic 250, Catalog Number MP01348 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets…
Category
Distribution
12 states
CriticalFDA (Devices)··2019-01-30
Draeger Medical Recalls VentStar Basic 250 Breathing Circuits Due to Assembly Error
Draeger Medical is recalling 170 units of VentStar Basic 250 breathing circuits because they were incorrectly pre-assembled, creating a risk of incorrect connection or short circuiting.
Product
VentStar Basic 250, Catalog Number MP00350 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets…
Category
Distribution
12 states
SevereFDA (Devices)··2019-01-30
Draeger Medical Recalls VentStar Basic Breathing Circuits Due to Assembly Error
Draeger Medical is recalling 75 units of VentStar Basic (P) 250 breathing circuits because they were incorrectly pre-assembled, creating a risk of incorrect connection or short circuit.
Product
VentStar Basic (P) 250, Catalog Number MP00352 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia…
Category
Distribution
12 states
SevereFDA (Devices)··2019-01-30
Draeger Medical Recalls 10 VentStar Anesthesia Breathing Circuits
Draeger Medical is recalling 10 units of VentStar Anesthesia WT(P) 180 breathing circuits due to incorrect pre-assembly that could cause incorrect connections.
Product
VentStar Anesthesia WT(P) 180, Catalog Number MP00374 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing…
Category
Distribution
12 states